Welcome to the Regulatory News section of medicines.org.uk This section provides details of the most recent news items from the MHRA, EMEA and the European Commission.
MHRA and UK News last update: 18 July 2008
EMEA News last update: 18 July 2008
European news and information last update: 18 July 2008.
Recent News
16.07.2008: Minutes from the Ministerial Industry Strategy Group (MISG) New Technologies Advisory Panel - 29 April 2008
The Advisory Panel discussed the progress on the earlier access to medicines and cardiovascular imaging forums, the plans for future forums on safety biomarkers and benefit-risk analysis.
16.07.2008: Advertising - Monthly performance on vetting of advertising – June 2008
11.07.2008: Advertising – new MHRA guidance
MHRA have developed new guidance for companies offering website-based treatment services to ensure that prescription only medicines are not promoted to the public.
07.07.2008: MHRA Drug Safety Update: Volume 1
07.07.2008: Periodic (annual) service fees for medicines licences for the period 1 April 2008 - 31 March 2009
01.07.2008: Variations – proposals to harmonise the handling of variations to national licences (consultation MLX352)
01.07.2008: Safety information on medicines for healthcare professionals sent in June 2008
20.06.2008: MHRA conference: Contract Good Manufacturing Practice (GMP) Quality Control (QC) Labs - 10 September 2008
20.06.2008: MHRA Review of unlicensed medicines
MHRA are currently reviewing the regulatory arrangements that exist in the UK which allow an authorised healthcare professional to commission an unlicensed medicinal product to meet the special needs of an individual patient. They have issued a reminder that the deadline for comment is 30 June 2008.
10.06.2008: MHRA - Monthly performance on vetting of advertising – May 2008
06.06.2008: User tested patient information – MHRA delays
MHRA have announced that there are some delays in the processing of applications for assessment of user tested patient information.
04.06.2008: MHRA Drug Safety Update – June 2008
03.06.2008: Safety information on medicines for healthcare professionals sent in May 2008
02.06.2008: Fees - Periodic (annual) service fees for medicines licences
MHRA have announced that invoices in for 2008/09 Annual Periodic Fees will be sent to all Product Licence Holders and Marketing Authorisation Holders.
02.06.2008: Latest advertising complaints
28.05.2008: Herbal medicines and the "sunset clause"
MHRA have published information about the Sunset Clause for holders of marketing authorisations of herbal products that are not currently marketed.
23.05.2008: Pharmacovigilance: Public consultation (MLX 350) on amendments to the Medicines for Human Use (Marketing Authorisations, etc.) Regulations 1994 to clarify pharmacovigilance reporting requirements
Deadline for comments: 15 August 2008
23.05.2008: European Periodic Safety Update Reports (PSUR) Synchronisation Project - Extension of the scheme
MHRA have reiterated that the products covered by this scheme have been expanded to include products authorised prior to 1976. Herbals, homeopathics and biologicals such as vaccines and blood products are still excluded from the scheme.
20.05.2008: Medical devices: European Commission questionnaire seeking views on proposals to further revise the medical devices Directives
15.05.2008: Counterfeit medicines: UK government response to European consultation on the legal proposal to combat counterfeit medicines for human use
09.05.2008: MHRA: Monthly performance on vetting of advertising - April 2008
08.05.2008: Better Regulation of Medicines Initiative (BROMI) - third report launched
06.05.2008: MHRA Drug Safety update - May 2008
02.05.2008: Determination of marketing authorisation (MA) applications made under the Decentralised and Mutual Recognition Procedures - update
02.05.2008: Updated Guidance for marketing authorisation application using the Decentralised procedure with the UK as Reference Member State (RMS)
29.04.2008: MHRA Corporate Plan, Business Plan and summary report of responses to public consultation on five-year strategy
25.04.2008: European Commission public consultation: Legal proposal on information to patients - MHRA response
25.04.2008: The "sunset clause": One-off exercise to establish the marketing status of all medicinal products on the UK market
Current medicines regulations state that if a product is placed on the market after authorisation, but subsequently ceases to be placed on the market in a Member State for a period of three consecutive years, its authorisation will also cease to be valid (the "sunset clause"). MHRA have announced that they will be conducting a one-off exercise to establish the marketing status of all medicinal products on the UK market. They will be contacting marketing authorisation holders about this after 12 May 2008, with responses required 12 July 2008.
22.04.2008: Latest complaints about the advertising of medicines
16.04.2008: MHRA conference: Better Regulation of Medicines Initiative (BROMI) Variations - Joint MHRA/ Industry Training Day - 8 May 2008
11.04.2008: Parallel import licences - user testing of patient information leaflets
10.04.2008: Monthly performance on vetting of advertising - March 2008
09.04.2008: Patient information leaflets
MHRA have announced that as a result of the large number of applications that are in the system, that some changes have been made to the assessment procedure for patient information leaflets:
- MHRA assessors are working in therapeutic areas to make best use of assessor experience.
- Compliance with the summary of product characteristics (SPC) is no longer part of the assessment process.
- The time to assessment will be prioritised according to known variables (particular test houses, companies or products).
With regard to the requirement for consultation with target patient groups, there is a deadline of 30 June 2008 for applications. It is a legal requirement that all products have an updated MA by 1 July 2008.
07.04.2008: MHRA Drug Safety Update - April 2008
04.04.2008: Outcome of consultation (MLX 345) on a risk-based inspection programme for good practice inspections
03.04.2008
: Latest complaint about the advertising of medicines
28.03.2008
: Clinical trials current issues: Applications for trials with integrin antagonists
28.03.2008
: Minutes: Advisory Board on the Registration of Homoeopathic Products (19 December 2007)
13.03.2008
: Determination of applications made under the decentralised and mutual recognition procedures
In accordance with Directive 2001/83 and commencing 1 April 2008, the MHRA will determine marketing authorisation applications for medicines submitted through the decentralised and mutual recognition procedures within the designated thirty day period from the conclusion of the procedure. MHRA have clarified that in accordance with Medicines Regulations, the medicine cannot be marketed in the UK until approval of the product labelling and leaflet mock-ups has been obtained.
05.03.2008: Minutes: British Pharmacopoeia Commission (10 December 2007)
05.03.2008: Minutes: British Pharmacopoeia Commission Expert Advisory Group MC3: Medicinal Chemicals (25 September 2007)
17.03.2008: Latest complaints about advertising of medicines
11.03.2008: Proposed changes to regulatory fees for medicines and medical devices
10.03.2008: Frequently asked questions about changes to the labels, patient information leaflets and packaging of medicines
06.03.2008
: Latest Complaints about advertising of medicines
05.03.2008: RPSGB and MHRA sign Memorandum of Understanding
03.03.2008: MHRA Drug Safety Update - March 2008
03.03.2008: MHRA Drug Safety Update: Volume 1, Issue 8, March 2008
03.03.2008: Safety information for healthcare professionals sent in February 2008
29.02.2008: MHRA Service fees for 2008/2009 - Reminder to cancel licences
MHRA have issued a reminder that all licences, registrations and marketing authorisations that are "live" on 1 April 2008 will be liable for a periodic fee for the next year unless cancelled before the end of March 2008.
28.02.2008: MHRA informal consultation paper on the review of the regulation of unlicensed medicines
26.02.2008 : Conference: Contract Good Manufacturing Practice (GMP) Quality Control (QC) Labs Symposium - 1 April 2008
25.02.2008: Clinical trial authorisations
MHRA have added a new section to their web site covering clinical trial information.
18.02.2008: Medicines – reporting of side effects by members of the public
MHRA have launched a campaign to encourage community pharmacists to mention the Yellow Card (YC) Scheme when they talk to their customers about their medicines.
11.02.2008: Manufacturer's and wholesale dealer's licences
04.02.2008: Safety information for healthcare professionals sent in January 2008
04.02.2008: Integrated Research Application System (IRAS)
An integrated application system (IRAS ) has been developed to simplify applying for approval or permission to conduct a piece of research in the National Health Service. The system allows researchers to enter information about their study in one place, and is designed to save time and effort by preventing duplication of information in separate application forms for each type of approval.
Further information: UK Clinical Research Collaboration (UKCRC) website
04.02.2008: Drug Safety Update: Volume 1, Issue 7, February 2008
04.02.2008: Medical devices: new vigilance reporting and guidance for the UK
04.02.2008: Forthcoming MHRA conferences
25.01.2008: Earlier access to medicines: Report from the Ministerial Industry Strategy Group (MISG) Forum
The second Forum set up under the Ministerial Industry Strategy Group (MISG) met in September 2007 to debate whether making medicines available to patients at an earlier stage of their development was feasible and desirable.
25.01.2008: Consultation MLX 347: Amendments to the Medicines for Human Use (Marketing Authorisations etc) Regulations 1994
MLX 347 seeks views on proposals to introduce measures in the UK to enforce the obligations set out in the Paediatric Regulation (Regulation 1901/2006).
23.01.2008: Additional guidance on patient information leaflet (PIL) user testing for parallel import licence (PLPI) products
23.01.2008: Conference: 25 years of POM to P: Engaging Men in their Healthcare - Widening Access to Medicines - 4 February 2008
23.01.2008: New appointment to the British Pharmacopoeia Commission
22.01.2008: Commission on Human Medicines - minutes - 6 December 2007
22.01.2008: Complaints about advertising of medicines
22.01.2008: Commission on Human Medicines - summary minutes - 6 December 2007
22.01.2008: Recent complaints about advertising of medicines
18.01.2008: Guidance for UK Manufacturer's Licence and Manufacturer's Authorisation Holders on the use of stand alone contract laboratories
16.01.2008: Chemistry, Pharmacy and Standards Expert Advisory Group summary minutes - 4 December 2007
14.01.2008: Biologicals & Vaccines Expert Advisory Group summary minutes - 3 December 2007
14.01.2008: Pharmacovigilance Expert Advisory Group summary minutes - 7 November 2007
11.01.2008: Ministerial Industry Strategy Group (MISG) New Technologies Advisory Panel
Minutes of the fourth meeting on 1 November 2007 have been issued.
07.01.2008: Conference - Statutory Good Clinical Practice (GCP) inspections of clinical laboratories - 5 March 2008
07.01.2008: Drug Safety Update - January 2008
The sixth issue of Drug Safety Update includes information on safety advice for statins, methylioninium chloride (methylene blue), and bivalirudin (Angiox); long-acting ß2 agonists in asthma management; and a summary of important emerging drug safety information, including the recommendation to suspend the marketing authorisations for carisoprodol.
03.01.2008: Proposals for changes to regulatory fees from 1 April 2008
The closing date for comments on MLX 334: MHRA regulatory fees for medicines is 9 January 2008.
03.01.2008: Safety information for healthcare professionals sent in December 2007
02.01.2008: Independent Scientific Advisory Committee for MHRA database research (ISAC) - new Chairman and members
20.12.2007: Medical devices - Guidance Note 1 - Guidance notes for manufacturers on clinical investigations to be carried out in the UK
20.12.2007: Paediatric Medicines Expert Advisory Group minutes - 13 November 2007
18.12.2007: MHRA MAIL 164
This issue of MAIL includes information on the paediatric regulation, risk management plans, and guidance on the submission of decentralised and centralised procedure applications.
14.12.07: Forthcoming MHRA conferences
10.12.2007: Commission on human medicines minutes - 8 November 2007
7.12.2007: Clinical Trials Expert Advisory Group summary minutes - 9 October 2007
26.11.2007: Medical devices: making medical device vigilance more effective - forthcoming changes in EU medical device vigilance guidance
23.11.2007: MHRA anti-counterfeiting strategy and new counterfeit reporting hotline launched
21.11.07: Advertising - MHRA annual report
20.11.2007: Clinical trials for medicinal products: MHRA Phase 1 Accreditation Scheme
MHRA will be implementing a national accreditation scheme for phase 1 clinical trials.
16.11.2007: Conference: Managing the recall of medicines - 11 December 2007
15.11.2007: Pharmacovigilance Service Desk
14.11.2007: Freedom of information: new guidance on how MHRA will deal with requests for information
New guidance has been issued on how the MHRA (and some other Government departments) will deal with requests for information under the Freedom of Information Act. This replaces the Memorandum of Understanding that had been in place since 2004.
Guidance on the disclosure of types of human and veterinary medicines information held by the human and veterinary regulatory authorities 14.11.2007: Conference: Good Clinical Practice (GCP) in Today's Changing Environment - 23 November 2007
13.11.2007: Conference: Maintaining Quality of Medicines in the Supply Chain - 10 December 2007
9.11.2007: Minutes: Pharmacovigilance Expert Advisory Group - 10 October 2007
5.11.2007: Minutes: British Pharmacopoeia Commission - 18 September 2007
1.11.2007: Minutes: Respiratory and allergy medicines expert advisory group - 13 June 2007
1.11.2007: Minutes: Commission on Human Medicines - 12 and 13 July 2007
05.11.2007: MHRA drug safety update - November 2007 issue
01.11.2007: Safety information for healthcare professionals sent in October 2007
1.11.2007: Minutes: Psychiatry and old age psychiatry expert advisory group - 3 May 2007
30.10.2007: Minutes: Commission on Human Medicines - 13 September 2007
25.10.2007: Minutes - Medicines for Women's Health Expert Advisory Group - 3 July 2007
25.10.2007: General Practice Research Database
MHRA have issued a press release encouraging those in the research community to apply to use data from the General Practice Research Database (GPRD) and the Yellow Card Scheme to help their studies to protect public health.
25.10.2007: Independent Scientific Advisory Committee for MHRA database research (ISAC) annual reports
The first annual report by the Independent Scientific Advisory Committee for MHRA database research (ISAC) has been published.
25.10.2007: Conference: Hot topics in advertising and information for patients - 21 November 2007
23.10.2007: Consultation on a risk-based inspection programme for good practice inspections (MLX 345)
MLX 345 seeks views on the MHRA proposal for implementing a revised risk-based inspection programme for good practice inspections.
22.10.2007: Recent advertising complaints
18.10.2007: MAIL 163
This issue includes: compliance with new legal requirements for patient information leaflets; an update on Periodic Safety Update Reports (PSUR) applications; the Pharmacovigilance Service Desk providing a service to marketing authorisation (MA) holders; and the Regulatory Information Service.
17.10.2007: Proposal - new fees for medicines from April 2008
This consultation seeks views on proposals to change the levels of fees charged by the MHRA for the regulation of medicines, including herbal and homoeopathic medicines, and blood establishments and blood banks.
17.10.2007: Conference: Good Clinical Practice (GCP) in today's changing environment -
This conference will be held on 23 November 2007 in Edinburgh.
12.10.2007: Minutes: Clinical Trials Expert Advisory Group summary minutes - 12 June 2007
11.10.2007: Minutes: Pharmacovigilance Expert Advisory Group - 12 September 2007
09.10.2007: Minutes: Patient information expert advisory group
26.09.2007: Minutes: Advisory Board on the Registration of Homoeopathic Products summary minutes - 29 November 2006
10.10.2007: MHRA Regulatory News web page
MHRA have introduced a section on their web site covering medicines regulatory information.
10.10.2007: MHRA Patient information leaflet (PIL) of the month
MHRA are promoting the user testing of patient information leaflets by publishing a series of examples to illustrate improvements and to aid learning.
02.10.2007: Consultation MLX 343
MHRA have issued a consultation on proposals to make the sale and supply of products containing more than 720mg pseudoephedrine and 180mg ephedrine subject to a prescription.
Deadline for comment: 13 November 2007
01.10.2007: MHRA Drug Safety Update - October 2007
28.09.2007: MHRA document: How we make regulatory decisions about medicines and medical devices
21.09.2007: Medical devices: final text of Directive 2007/47/EC
The European Commission has published the final text of Directive 2007/47/EC, which revises the Medical Devices and Active Implantable Medical Devices Directives.
20.09.2007: Independent Scientific Advisory Committee for MHRA database research (ISAC) - appointment of three further members
The Appointments Commission is currently undertaking a recruitment exercise on behalf of the MHRA to appoint up to three new professional members to the Independent Scientific Advisory Committee for MHRA database research (ISAC).
17.09.2007: Latest advertising complaints
17.09.2007: Pharmacovigilance Expert Advisory Group minutes - 11 July 2007
13.09.2007: Electronic Patient Records - House of Commons Health Committee Report
The House of Commons Health Committee have published their report on The Electronic Patient Record. The 117 page report includes a large number of recommendations for the Electronic Patient Record systems, the Summary Care Record (SCR) , the Detailed Care Record (DCR) , and the Secondary Uses Service (SUS).
11.09.2007: Complaints about advertising of medicines
07.09.2007: Appointments to the British Pharmacopoeia Commission
The British Pharmacopoeia Commission is currently seeking to appoint two new members from 1 January 2008.
05.09.2007: 2007/08 Annual service fee invoices and accompanying fee schedules
MHRA have confirmed that all invoices have now been dispatched to licence holders that were not correctly charged initially.
04.09.2007: Safety information on medicines for healthcare professionals sent in August 2007
03.09.2007: Drug Safety Update: Volume 1, Issue 2, September 2007
This includes information about hormone replacement therapy, desmopressin, and corticosteroids; a summary of what to report via the Yellow Card scheme; and recent drug safety letters sent to healthcare professionals.
30.08.2007: Consultation (MLX 341): Proposal for a voluntary accreditation scheme for Phase I Clinical Trial Units in the UK
This consultation seeks views on proposals for a voluntary accreditation scheme for Phase I Clinical Trial Units in the UK.
29.08.2007: Forthcoming MHRA conferences
28.08.2007
: Optometrists to get independent prescribing powers
It has been announced that optometrists will be able to train to prescribe medicines.
22.08.2007: Independent Scientific Advisory Committee for MHRA database research (ISAC) minutes - 10 May 2007
17.08.2007
: Consultation MLX 342: Proposals to enable UK pharmacists to dispense prescription only medicines prescribed by doctors and dentists registered in European Member States and Switzerland
17.08.2007
: Consultation MLX 340: Amendments to the Medicines for Human Use (Clinical Trials) Regulations 2004
Proposed changes to the legislation include: allow trials of emergency care medicines in children without initial consent; clarify which trials require ethical review by the Gene Therapy Advisory Committee; and provide greater flexibility in the operation of ethics committees and their appointing authority.
15.08.2007: Department of Health and MHRA Register of Licensed Wholesale Dealer Sites (Human Veterinary and Combined Sites) 2007
10.08.2007
: Consultation MLX 339: Challenges and priorities for the MHRA -
02.08.2007: Conference: Combating counterfeit medicines- 22 November 2007
01.08.2007: Drug Safety Update: Volume 1, Issue 1, August 2007
MHRA have introduced a monthly electronic bulletin for health professionals. the first issue includes: drug safety advice for gadolinium-containing contrast agents, Extraneal, dopamine agonists, and antidepressant use in young adults; reporting trends and latest data from the Yellow Card scheme; and recent drug safety letters sent to healthcare professionals.
01.08.2007: Safety information on medicines for healthcare professionals sent July 2007
01.08.2007: Requests for MHRA to act as Reference Member State (decentralised procedures)
Companies are now requested to contact MHRA six months before wanting them to act as Reference Member state in the decentralised procedure.
30.07.2007: Latest complaints about advertising of medicines - July 2007
27.07.2007: Conference: Next Steps in Good Clinical Practice (GCP) for non-commercials - 24 September 2007
26.07.2007: Herbal Medicines Advisory Committee minutes - 28 March 2007
26.07.2007: MHRA Annual Report and Accounts 2006/07
24.07.2007: MHRA's RamaXL now available outside the UK
MHRA's RamaXL (previously RAMA), a subscription service that gives subscribers the ability to track their own applications as they progress through the assessment process, plus access to non-confidential information on all medicinal products authorised in the UK is now available to both UK and overseas subscribers.
24.07.2007: MAIL 162
The latest issue of the MHRA's newsletter for marketing authorisation holders includes:
-
MHRA best practice guidance to processing national marketing authorisation (MA) applications - pilot phase
- fast tracking of marketing authorisation (MA) applications
- requests for notification of inspections performed in the UK by overseas Inspectorates
- patient information leaflets (PILs) - reminder about compliance with new legal requirements
(Directive 2001/83)
- pharmacovigilance inspection metrics reports
- EU infringement regulation for centrally authorised products
- MHRA current events for 2007
23.07.2007 : Commission on Human Medicines summary minutes - 14 and 15 June 2007
20.07.2007: Pharmacovigilance Expert Advisory Group summary minutes - 13 June 2007
19.07.2007: Errors in MHRA 2007/08 annual service fee invoices / fee schedules
MHRA have identified a problem affecting a small number of Marketing Authorisation (MA) Holders who received invoices and corresponding fee schedules in May and June 2007 relating to the 2007/08 Service Fee for an incorrect amount. Some companies were either charged for most but not all of the licences that were held as at 1st April 2007 or for licences which they had previously asked to be cancelled. MHRA expect to raise an additional invoice and corresponding fee schedule in August to capture those licences that were not charged initially.
16.07.2007: British Pharmacopoeia Commission summary minutes - 4 June 2007
09.07.2007: Biologicals & vaccines expert advisory group summary minutes - 14 May 2007
06.07.2007: "Sunset clause": Questions and answers
MHRA has issued questions and answers on the "sunset clause" which refers to the statutory requirements to inform the Licensing Authority (the MHRA in the UK) of any disruptions to supply of medicines.
05.07.2007: MHRA publication: Medicines & Medical Devices Regulations: What you need to know
This provides an introduction to the MHRA, and how it regulates medicines and medical devices in the UK.
03.07.2007: Medicines for Women's Health Expert Advisory Group summary minutes - 24 April 2007
02.07.2007: Fast tracking of marketing authorisation applications
The criteria and procedures to allow marketing authorisation applications to be fast tracked have been made available.
02.07.2007: Commission on Human Medicines summary minutes - 17 May 2007
02.07.2007: Forthcoming MHRA conferences
- Using the British Pharmacopoeia Effectively - 31 October 2007
- Liaison Officer Conference - 2 November 2007
- Hot Topics in Advertising - 21 November 2007
- MHRA Combating Counterfeit Medicines Seminar - 22 November 2007
02.07.2007: Safety information on medicines for healthcare professionals sent in June 2007
29.06.2007: Ministerial Industry Strategy Group Forum on the use of imaging techniques in cardiovascular drug development
The report of the first Forum of the Ministerial Industry Strategy Group (MISG), held on 4 May 2007, is now available.
27.06.2007: User testing of patient information leaflets for medicines: Clarification on success criteria
In response to a recent article in the "Regulatory Rapporteur Journal" about user testing of patient information leaflets, MHRA have issued a corrected interpretation of the success criteria.
27.06.2007: UKCRC (UK Clinical Research Collaboration) R&D Advisory Group to Connecting for Health - Report of the research simulations
The report highlights the technical, regulatory and governance issues related to using the NHS Care Records Service as a platform for high quality health research. As an outcome of this report, the Department of Health's Director General of R&D and the NHS CfH Director of IT Services, the UKCRC Advisory Group's sponsors, will be developing a programme of work to begin to address the recommendations. This programme of work will be taken forward in tandem with measures to strengthen information governance of health information for uses other than direct patient care.
22.06.2007: Traditional herbal medicines directive - opportunity to comment on operation
The European Commission issued a draft report for public consultation on experience acquired as a result of the early operation of the Directive on traditional herbal medicinal products.
Deadline for comments: 13 July 2007
19.06.2007: Rules and Guidance for Pharmaceutical Distributors 2007
This publication reproduces those elements of the 2007 edition of "Rules and Guidance for Pharmaceutical Manufacturers and Distributors" (the "Orange Guide") specific to the wholesale supply and distribution of medicines for human use.
19.06.2007: PILs - MHRA survey on use of Risk Communication guideline in development of PILs
MHRA have developed a survey to find out how the Risk Communication guideline published in the "Always Read the Leaflet" publication is currently being used in the development of patient information leaflets, and what areas could be improved in order to facilitate implementation of the principles.
All companies that produce licensed medicines are invited to complete the survey.
Deadline for comments: 1 August 2007
18.06.2007: Latest complaints about advertising of medicines
18.06.2007: MHRA at NHS Confederation annual conference
MHRA will have a stand at the NHS Confederation annual conference and exhibition to be held at ExCel, London, on 20-22 June.
15.06.2007: MHRA second communications strategy - April 2007 to March 2010
13.06.2007: Pharmacovigilance Expert Advisory Group summary minutes - 16 May 2007
13.06.2007: Clinical Trials Expert Advisory Group summary minutes - 18 April 2007
13.06.2007: Guidance note for parallel import (PLPI) companies on user testing of patient information leaflets
08.06.2007: Clinical trials time-based performance measures
MHRA have announced that the Clinical Trials Unit performance measures for clinical trial authorisation (CTA) applications will be published their website and updated monthly.
08.06.2007: Proposed voluntary accreditation scheme for Phase 1 Clinical Trial Units
Following on from the TGN1412 incident, in March 2006, where six trial subjects became seriously ill and were admitted to intensive care, and in response to the recommendations of the Expert Scientific Group, the MHRA Good Clinical Practice (GCP) Inspectorate is seeking to implement an accreditation scheme for units conducting non-therapeutic studies.
08.06.2007: Recent MHRA Drug Alerts (counterfeit and contaminated products)
08.06.2007: MHRA best practice guidance for processing national marketing authorisation applications - pilot phase
MHRA have announced the pilot of this best practice guidance for processing national marketing authorisation (MA) applications. The purpose of the pilot is to review initiatives in order to improve the transparency and predictability of purely national MA procedures.
06.06.2007: MHRA forthcoming conferences
04.06.2007: Safety information on medicines for healthcare professionals sent in May 2007
This provides a list of the letters sent to healthcare professionals in May 2007, giving safety information and advice on medicines.
01.06.2007: New European regulation on tissue engineering to benefit patients
European Health Ministers have agreed on a Regulation on advanced therapy medicinal products (ATMPs), including tissue engineering.
30.05.2007: MAIL 161
This issue includes clarification of the fee applicable for product licence applications and variations which are electronic Common Technical Document (eCTD) compliant.
25.05.2007: Independent Scientific Advisory Committee for MHRA database research (ISAC)
21.05.2007: Commission on Human Medicines summary minutes - 19 April 2007
25.05.2007: Independent Scientific Advisory Committee for MHRA database research (ISAC)
16.05.2007: Pharmacovigilance Expert Advisory Group summary minutes - 18 April 2007
16.05.2007: British Pharmacopoeia Commission summary minutes
15.05.2007: MHRA Business Plan for 2007/08 and Corporate Plan for 2007/08 to 2011/12
10.05.2007: MHRA conference: Using the British Pharmacopoeia effectively
This conference will take place on Wednesday 31 October 2007 in London.
08.05. 2007: MHRA pharmacovigilance inspection metrics 2006
08.05. 2007: MHRA at this year's NHS Confederation annual conference
MHRA will, for the first time, have a stand at the NHS Confederation annual conference and exhibition to be held at ExCel, London, on 20-22 June.
04.05. 2007: Conference - Regulation Matters: an information day about the work of the MHRA - 27 June 2007
01.05.2007 : Safety information on medicines for healthcare professionals sent in April 2007
This provides a list of the letters sent to healthcare professionals in April 2007, giving safety information and advice on medicines.
27.04.2007: Patient information leaflets for medicines: Work plan to monitor progress in achieving quality improvements
The Commission on Human Medicines Expert Advisory Group on Patient Information has developed a work plan to monitor progress in achieving quality improvements to patient information leaflets (PILs), increase access to patient information and influence the regulatory framework at European level. MHRA have added examples of PILs demonstrating aspects of best practice on their web site.
25.04.2007: Commission on Human Medicines - summary minutes
19.04.2007: Pharmacovigilance Expert Advisory Group summary minutes - 14 March 2007
20.04.2007: MAIL 160
This issue includes a proposal for MHRA fees; when risk management plans (RMP) are required, and guidance for notification of serious breaches of good clinical practice (GCP) or the trial protocol.
12.04.2007: Pharmacovigilance Inspections conference - 20 June 2007
02.04.2007: Safety information on medicines for healthcare professionals sent in March 2007
This provides a list of the letters sent to healthcare professionals in March 2007, giving safety information and advice on medicines.
29.03.2007: Conference: Countdown to e-Working in 2008
MHRA will be holding a conference "Countdown to e-Working" on 27 June 2007 in London.
28.03.2007: MHRA document: How regulatory decisions are made
MHRA have drafted a document which sets out the principles that inform regulatory decisions about medicines and medical devices.
28.03.2007: Herbal Medicines Advisory Committee summary minutes - 31 January 2007
26.03.2007: Dermatology expert advisory group summary minutes - 17 August 2006
23.03.2007: Anti-infective HIV and AIDs expert advisory group summary minutes - 2 June 2006
22.03.2007: Commission on human medicines and industry forum meeting - 13 September 2006
22.03.2007: Public consultation: MLX 336 - Patient Group Directions
MLX 336 seeks view on proposals to expand the range of Controlled Drugs which can be supplied or administered by nurses and pharmacists working under Patient Group Directions (PGDs).
Deadline for comment: 20 April 2007
The consultation document also includes proposals to expand the use of Patient Group Directions in the independent healthcare sector in Northern Ireland, and proposals to correct a technical error in the legislation on use of Patient Group Directions in the private sector. The deadline for comment on these proposals is 15 June 2007.
22.03.2007: Public consultation (MLX 338): independent prescribing of Controlled Drugs by nurse and pharmacist independent prescribers
MLX 338 seeks views on the range of Controlled Drugs that can be prescribed independently by Nurse Independent Prescribers and a proposal to enable Pharmacist Independent Prescribers to independently prescribe Controlled Drugs.
21.03.2007: Oncology and haematology expert advisory group summary minutes - 6 December 2006
21.03.2007: Chemistry, pharmacy and standards expert advisory group summary minutes - 13 February 2007
21.03.2007: Biologicals and vaccines expert advisory group summary minutes - 12 February 2007
21.03.2007: Biologicals and vaccines expert advisory group summary minutes - 6 November 2006
21.03.2007: Licensing of medicines: time-based performance measures
MHRA have started to publish time-based performance measures for various aspects of their information processing and licensing activities to provide guidance to medicines licence applicants on expected timings. They are based on data from the MHRA Sentinel workflow management system and, where necessary, on European procedure tracking system data. The charts will be updated monthly. They include:
19.03.2007: Qualified Person (QP) declaration in respect of the Good Manufacturing Practice (GMP) status of active substance manufacturers
MHRA have issued detailed guidance on the content and presentation of the QP (Qualified Person) declaration required.
15.03.2007: Pharmacovigilance expert advisory group summary minutes - 14 February 2007
15.03.2007: PILs - MHRA further guidance on designing patient information leaflets and how to achieve success in user testing
MHRA have issued additional guidance on user testing of patient information leaflets.
14.03.2007: Licensing of medicines: submission of applications in non-XML electronic Common Technical Document (eCTD) format
To help companies move to electronic Common Technical Document (eCTD) working, MHRA will now accept electronic submissions that are compliant with the folder structure and naming conventions of the eCTD standard but which do not have an XML backbone.
14.03.2007: Latest complaints about advertising of medicines
13.03.2007: Additives in children's medicines - MHRA response to Food Commission survey
MHRA have produced a press release in response to a survey published by The Food Commission on the use of additives in children's medicines.
12.03.2007: Ministerial Industry Strategy Group - Long-Term Leadership Strategy
The Ministerial Industry Strategy Group (MISG) has been developing a Long-Term Leadership Strategy (LTLS) to improve the UK and European environments for medicines. A report making a number of recommendations which will be progressed over the coming months has been published.
12.03.2007: Proposals for MHRA fees for medicines, blood banks and establishments from 1 April 2007
09.03.2007: New Technologies Advisory Panel - minutes from first meeting
MHRA have published the minutes from the MISG (Ministerial Industry Strategy Group) New Technologies Advisory Panel inaugural meeting and are inviting proposals for topics to be discussed at the next meeting in April.
07.03.2007 : Public consultation MLX 337
This concerns proposals to restrict the availability of medicines containing pseudoephedrine and ephedrine by a change to legal status from pharmacy (P) to prescription only (POM) together with a restriction in pack size.
Deadline for comments: 1 June 2007.
MLX 337
05.03.2007: MHRA regulatory guidance - Principles for variations procedures
02.03.2007: PIL user testing - report of MHRA survey
MHRA have published a report of the findings of the survey of user test houses undertaken on behalf of the Commission on Human Medicines Expert Advisory Group on Patient Information (CHMEAGPI).
02.03.2007: Safety information on medicines for healthcare professionals sent in February 2007
This provides a list of the letters sent to healthcare professionals in February 2007, giving safety information and advice on medicines.
01.03.2007: MHRA information day - Regulation Matters - 27 June 2007
This event will take place on 27 June 2007. This seminar will provide a framework for raising regulatory awareness and will address the principles of safety, quality and efficacy underlying the foundations of the Agency.
23.02.2007: New guidance on reporting breaches of Good Clinical Practice (GCP) or the trial protocol
The MHRA have issued new guidance for the notification of serious breaches of GCP or the trial protocol.
23.02.2007 : Conference: New requirements for patient information leaflets: how to submit
This conference will take place on 17 May 2007.
20.02.2007: Office of Fair Trading Report on UK drug pricing scheme
The OFT have recommended that the Pharmaceutical Price Regulation Scheme (PPRS) should be reformed. A link to their report is provided below.
Note: The OFT have changed the web reference for the press release and report (new links below).
15.02.2007: Pharmacovigilance Expert Advisory Group summary minutes - 17 January 2007
14.02.2007: Department of Health and MHRA register of licensed manufacturing sites (human, veterinary and combined sites) 2007
13.02.2007: Updated "Orange Guide" 2007
The 2007 edition of "Rules and guidance for pharmaceutical manufacturers and distributors"', commonly known as the 'Orange Guide', has been published.
09.02.2007: Medicines for Women's Health Expert Advisory Group minutes - 11 October 2006
08.02.2007
: Advertising of medicines: Vetting procedure survey
MHRA's Advertising Standards Unit is carrying out a survey to review the vetting procedure for advertising material. The MHRA pre-vets promotional material for all newly licensed medicines.
07.02.2007: Press release: Widening the availability of medicines to women
07.02.2007: Clinical trials for medicines: applications for first time in man (FTIM) trials with higher risk molecules
MHRA have proposed that, for certain FTIM trials, they will seek advice from an Expert Advisory Group (EAG)/Commission on Human Medicines (CHM) before approval for the trial can be given.
07.02.2007: Latest complaints about advertising of medicines
06.02.2007: MAIL 159
This issue includes an article on disruptions to the supply of medicines and interpretation of the "Sunset Clause" and information on requesting the MHRA to act as Reference Member State (RMS) in decentralised procedures.
06.02.2007: Better Regulation of Medicines: national informed consent (Article 10c, "simple abridged" applications
The process for approval of national informed consent (Article 10 c, "simple abridged applications") has been reviewed within the Better Regulation of Medicines Initiative (BROMI), and a checklist has been devised to improve the quality of applications.
06.02.2007: MHRA commissioned research: results from pharmacoepidemiology commissioning exercise
MHRA have announced that, following this exercise, three contracts have been awarded.
02.02.2007: Patient Information Expert Advisory Group summary minutes - 27 July 2006
02.02.2007: Patient Information Expert Advisory Group summary minutes - 25 May 2006
01.02.2007: Herbal Medicines Advisory Committee summary minutes - 17 November 2006
01.02.2007 : Herbal Medicines Advisory Committee summary minutes - 17 November 2006
29.01.2007: Latest complaints about advertising of medicines
23.01.2007 : Register of holders of manufacturer's authorisations for investigational medicinal products (MIAIMP)
23.01.2007: MHRA's third Annual Lecture - 'Biological solutions for health care - in the NHS?'
MHRA have issued a copy of the lecture made at the MHRA's third Annual Lecture at the British Museum on 17 January 2007 by Smith & Nephew Chief Executive, Sir Christopher O'Donnell.
Biological solutions for health care - in the NHS? (pdf document) 23.01.2007: Forthcoming MHRA conferences
The following MHRA conferences are currently planned:
- 5 February 2007 - New requirements for patient information leaflets: how to submit successfully (fully booked)
- 5 February 2007 - Medicines for children workshop
- 5 February 2007 - Working with the new medicines legislation and new regulatory pathways
- 5 February 2007 - Risk management planning seminar
- 5 February 2007 - Blood safety and quality regulations seminar
- 5 February 2007 - Practical Ways of e-working with the MHRA
- 6 February 2007 - Widening access to Medicines - Focus on Women's Health
- 6 February 2007 - Pharmacovigilance seminar
- 6 February 2007 - Lessons from TGN1412 - the impact on phase 1 clinical trials seminar
- 6 February 2007 - Current developments and medical device directives: a regulator's perspective
- 28 February 2007 - Inhalation technology and innovation
- 8 March 2007 - Pharmacovigilance inspections seminar
19.01.2007: Commission on Human Medicines summary minutes - 7 and 8 December 2006
18.01.2007 : Pharmacovigilance Expert Advisory Group summary minutes - 6 December 2006
17.01.2007: Chemistry, Pharmacy and Standards Expert Advisory Group summary minutes - 5 December 2006
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