May 2008

• MHRA Launches Third Report on Better Regulation of Medicines Initiative (9 May 2008)
  The Medicines and Healthcare products Regulatory Agency (MHRA)published its third report on the new and innovative scheme; Better Regulation of Medicines Initiative (BROMI) on 08 May 2008. BROMI is a ground breaking initiative which is changing medicines regulation in order to deliver new updated medicines to patients faster.
• US FDA Releases the Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan For Comment (5 May 2008)
  FDA is announcing the availability for public comment of the draft drug safety 5-year plan entitled ``Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan.'' This plan is intended to communicate FDA's strategy for meeting the commitments for enhancing and modernizing the drug safety system within the context of the PDUFA IV program.

April 2008

• Top Level Meeting Held Between the EDQM and the Indian Authorities (30 April 2008)
  The EDQM, the Ministry of Health of India and the Indian Pharmacopoeia Commission (IPC) held a meeting recently to discuss how to strengthen their working relationship in order to improve the quality of medicines in Europe and India.

• US FDA Embarks on Major Hiring Initiative for its Public Health Mission (30 April 2008)
  The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation.

• EMEA Releases Reflection Paper on Benefit-Risk Assessment Methods (23 April 2008)
  The European Medicines Agency is proposing a number of measures to improve the assessment of benefit and risks of medicines. The proposals, drawn up by a working group of the Agency’s Committee for Medicinal Products for Human Use (CHMP) are designed to increase consistency, transparency and communication of the CHMP’s benefit-risk assessment. They also include a number of recommendations for further research into risk-benefit assessment methodologies

• Congressional Testimony of Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs on "FDA Actions to Improve Safety of Medical Products with Foreign Components" (22 April 2008)
  Dr. von Eschenbach outline the Agency’s systems-based approach to address challenges for the import safety system.

• Public consultation on revisions of GMP Part II on Basic Requirements for Active Substances used as Starting Materials (16 April 2008)
  An amendment is proposed to Part II of the GMP Guide to incorporate principles of Quality Risk Management as laid down in the ICH guideline Q9, which also correspond to similar changes made to Part I Chapter 1 of the Guide and published in February 2008.

• Public consultation on revisions of GMP Annex 13 on Investigational Medicinal Products (16 April 2008)
  Based on practical experiences a revision of the Annex was deemed necessary to clarify certain points related to reference and retention samples, the two-step release procedure for investigational medicinal products and to the principle of independence between production and quality control functions.

• ICH Releases New topic : Q11 Development and Manufacture of Drug Substances (chemical entities and biotechnological/biological entities) (15 April 2008)
  The Concept Paper and Business Plan are available here
• Public consultation on revisions of GMP Annex 11 on Computerized Systems and related changes in GMP Part I/ Chapter 4 on Documentation (11 April 2008)
  The Annex has been updated in response to the increased use of computerised systems and the increased complexity of these systems. Consequential amendments are also proposed for Chapter 4 of the GMP Guide (Documentation).  Comments should be sent to entr-gmp@ec.europa.eu and GMP@emea.europa.eu by 31 October 2008.
• Implementation of the Advanced Therapies Regulation: public consultation on the revision of Annex I to Directive 2001/83/EC  (10 April 2008)
  Regulation (EC) No 1394/2007 on advanced therapy medicinal products will apply from 30 December 2008. The European Commission services have published on 13 December 2007 an implementation plan, outlining their priorities for the implementation of the Regulation. As part of this plan, the Commission intends to revise Part IV of Annex I to Directive 2001/83/EC in order to adapt it to the specificities of advanced therapy medicinal products. This public consultation document presents preliminary proposals to replace the existing Part IV of this Annex I.
• Pan American Health Organization (PAHO) Initiative - Proposed Harmonized Requirements for the Licensing of Vaccines in the Americas (10 April 2008)
  The purpose of these documents is to achieve greater harmonization in the information submitted in the application for Market Authorization of vaccines for human use. They apply to all vaccines to be registered, regardless of whether they are manufactured in the country of origin or not. Since the same information should be submitted to all countries in the Americas, the licensing process and ultimately the availability of vaccines should be facilitated. It is expected that having a common document will also benefit the region by making more efficient use of technical and financial resources, as well as facilitating mutual recognition processes where appropriate.
• TGA Publishes A History of Therapeutic Goods In Australia by John McEwan (9 April 2008)
  The TGA today represents the product of a long history of evolution of therapeutic products regulation in Australia. This publication aims to capture this evolutionary process not only as an interesting example of the development and role of a regulator but also to understand the directions for the future. The book covers the periods from the early 1900s up to the present.
• Revision of the  PIC/S Guide to Good Practices For the Preparation of Medicinal Products in Healthcare Establishments(PE 010-2) (4 April 20087)
  The PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010-2) has been revised in order to correct a misprint at Annex 1. The revised Guide entered into force on 1 April 2008.
• US FDA Publishes Slides:  Overview of the Regulation of Biological Products (Blood Components and Tissues) 
  Includes 5 slide presentations on the following topics:  Surveillance and Enforcement; The Regualtion of Biological Products; The Regualtion of Biological Products - Review; FDA Field Inspections; and FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products. 

March 2008

• EMEA Press Release - Towards an optimal balance between benefits and risks for veterinary medicines (31 March 2008)
  Representatives of European and national regulators as well as the Animal Health Industry met on the 13th and 14th March for the 2008 Infoday with the central theme “Balancing the benefits and risks of veterinary medicinal products”  highlighting one of the core areas in the on-going discussion on ‘better regulation’ of veterinary medicinal products.
• Health Canada Addresses Biosimilars in "Consultation on Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)" (24 March 2008)
  Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of health products available in Canada, recognises that with the expiration of patents for biologic drugs, there will be the introduction of subsequent entry versions of biologic drugs. This document provides guidance to sponsors on information and regulatory requirements for subsequent entry biologic (SEB) products* in Canada.
• UMC and ICH MedDRA Management Board Announce MedDRA’s Implementation in Vigibase (21 March 2008)
  The WHO Collaborating Centre for International Drug Monitoring (Uppsala Monitoring Centre - UMC) and the ICH MedDRA Management Board are pleased to announce the implementation of MedDRA in the WHO global ICSR database (Vigibase). This completes a one-year project between the UMC and the MedDRA Management Board to make Vigibase processes as compatible with MedDRA as they are currently with WHO-ART.
• US FDA Unveils New Home Page Redesign (18 March 2008)
  It has a "layered" approach that allows you to find information quickly. Structure is improved to provide for easy scanning. Content is presented in plain language to make it more understandable.
• FDA Takes Next Step in Establishing Overseas Presence (14 March 2008)
  The U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government. 
• Health Canada Publishes Spring Edition of Theraputic Product Directorate Newsletter  (14 March 2008)
  Reports on issues including Health Canada's growing relationship with India, new product monographs, MBD workload update, Pharmaceuticals Workload Management update, and more.
• FDA Names Permanent Director for Center for Drug Evaluation and Research (11 March 2008)
  FDA Commissioner, Andrew von Eschenbach announced that Janet Woodcock MD has been appointed the permanent director of CDER.
• The Proceedings of the ICH Tokyo Symposium : Hot Topics and Influence on Asia (4 March 2008)
  Provides documents from ICH's first regional public meeting entitled "ICH Tokyo Symposium:  Hot Topics and Influence on Asia."
• FDA Commissioner Speech, FDA at a Turning Point: Meeting the Challenge of a Rapidly Changing World (4 March 2008)
  In this speech, Commissioner von Eschenbach addressed how the world has rapidly and radically changed, why these changes have brought FDA has to a turning point,  and what is being done to re-create the FDA.

February 2008

• Corrigendum To The PIC/S GPP Guide (25 February 2008)
  Following a misprint at Annex 1 of the recently adopted PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments (PE 010-1), the PIC/S Secretariat has published a corrigendum which is available on the "PIC/S Guides" page of the PIC/S website.
• Finland's National Agency For Medicines Publishes Strategic Targets 2008-2012 (27 February 2008)
  The strategy of the National Agency for Medicines states our mission and values, defines our clients and describes the operational environment.
• Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions [PDF] or [HTML] (20 February 2008)
  This document describes a process for the evaluation and recommendation by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions.
• UK Urges Members of the Public to be Encouraged by Pharmacists to Report Suspected Side Effects of Medicines (18 February 2008)
  MHRA launched a six-week campaign to get community pharmacists to mention the Yellow Card (YC) Scheme when they talk to their customers about their medicines.
• EMEA Implementation of Electronic-Only Submissions and  eCTD Submissions in the Centralised Procedure  (5 February 2008)
  The European Medicines Agency (EMEA) has unveiled plans for a phased approach to the acceptance of electronic-only and eCTD applications in support of marketing-authorisation applications for medicinal products in the centralised procedure.

• Recommendations on Ethical Aspects of Clinical Trials in Children Published  (5 February 2008)
  New recommendations have been published that are intended to contribute to the protection of children in clinical trials, while also facilitating and harmonising the conduct of such trials across the EU.  The recommendations were drawn up by the European Commission-led ‘Ad hoc group for the development of implementing guidelines for Directive 2001/20/EC’, with the EMEA acting as rapporteur.

• President's FY 2009 Budget Advances Food and Medical Product Safety, and the Safety of FDA-Regulated Imports (4 February 2008)
  The U.S. Food and Drug Administration, part of the U.S. Department of Health and Human Services, is requesting nearly $2.4 billion to protect and promote public health as part of the President's fiscal year (FY) 2009 budget—a 5.7 percent increase over the budget that the FDA received for the current fiscal year.
• PIC/S - EMEA CO-OPERATION AGREEMENT (1 February 2008)
  The Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the European Medicines Agency (EMEA) have agreed to strengthen their co-operation in the field of Good Manufacturing Practice (GMP) with a view to sharing resources and avoiding the duplication of activities.
• Nordic Market for Medicinal Products - Iceland and Sweden in a pilot project (1 February 2008)
  A Nordic working group explores the possibility of a common Nordic market for medicinal products. The working group has decided to start a pilot project with the participation of Iceland and Sweden.
• China's Vice-premier urges all-out effort for food, drug safety (1 February 2008)
  Chinese Vice-Premier Wu Yi called on January 31,2008 for an all-out effort to ensure food and drug safety through improved supervision, supply and rule of law.  Wu made the call at the opening of the annual working conference on the supervision of food and drug safety. She pledged to ceaselessly deepen the current special safety campaign.
• Annex I: Residue on Ignition/Sulphated Ash General Chapter [PDF] or [HTML] This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. 

January 2008

• Australia's TGA Publishes the 15th Revised Edition of Guidance on the GMP clearance of overseas medicine manufacturers (31 January 2008)
  The purpose of this guidance document is twofold. It is intended to provide information to sponsors and manufacturers on the acceptable form of evidence of GMP compliance for overseas manufacturers, and, outline how to submit such evidence to the TGA for assessment. It is not intended to provide a definitive list of the forms of evidence that are considered acceptable or unacceptable.

• UK's MHRA Releases Guidance for UK Manufacturer's Licence and Manufacturer's Authorisation Holders on the Use of Stand Alone Contract Laboratories (18 January 2008)
  MHRA published new guidance giving advice on the use of stand alone contract laboratories.

• Netherlands Medicines Evaluation Board Unveiling a New Website (18 January 2008)
  At 17:00 on 23 January 2008, Netherland's MEB will unveil their new website.  The current website is accessible as usual up until then. The web address remains unchanged at www.cbg-meb.nl.

• UK response to the European Commission's public consultation paper "Better Regulation of Pharmaceuticals: towards a simpler, clearer and more flexible framework for variations" (14 January 2008)
  MHRA published their response to the EC's consultation paper in this document.

• Closer ties on medicines safety between European and Canadian regulatory authorities (11 January 2008)
  The regulatory experts from the European Union and Canada will from now on be able to exchange confidential information about the authorisation and safety of medicines.

• Q8(R1) Pharmaceutical Development Revision 1 (11 January 2008)
  This guidance is an annex to ICH Q8 Pharmaceutical Development and provides further clarification of key concepts outlined in the core guideline.  It also describes the principles of Quality by Design.

• FDA Commissioner Names Directors to Food Safety and Veterinary Centers (7 January 2008)
  Stephen F. Sundlof, D.V.M., Ph.D., is moving from director of FDA's Center for Veterinary Medicine (CVM) to director of FDA's Center for Food Safety and Applied Nutrition (CFSAN). Bernadette Dunham, D.V.M., Ph.D., who is deputy director of CVM, will assume directorship of CVM, also effective Monday.

• China and the Unites States Signing Agreement on the Safety of Drugs and Medical Devices (2 January 2008)
  The State Food and Drug Administration and the U.S. Department of Health and Human Services signed the Agreement between the Department of Health and Human Services of the United States of America and the State Food and Drug Administration of the People's Republic of China on the Safety of Drugs and Medical Devices at Diaoyutai State Guest House in Beijing, which symbolizes a substantive progress in strengthening cooperation and securing consumer safety of drug use between the two countries.
  

Regulatory News Archives 2007
Regulatory News Archives 2006