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Regulatory Review: Insight from ISPE Regulatory Advisors March 2008: Revision of EU GMP Guidelines  by Robert M. Tribe The EMEA announced on 18 February 2008 several significant revisions to the EU Guidelines to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP Guidelines). These included revisions to Part I, Chapter 1 (Quality Management) and Annex 1 (Manufacture of Sterile Medicinal Products), as well as the inclusion of a new Annex 20 on Quality Risk Management.  Continue reading Regulatory Review Article Archives

Regulatory News:

• US FDA Releases the Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan For Comment
  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.

• Top Level Meeting Held Between the EDQM and the Indian Authorities
  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 
  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
  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