PIC/S adopts EU GDP Guidelines
The Pharmaceutical Inspection Co-operation Scheme PIC/S has published a PIC/S Guide to GDP. This Guide is based on the EU GDP-Guidelines (2013/C 343/01) and quotes the EU Guide almost completely.
Focus on enforcement review of pharmaceutical manufacturing and production sector
The Department of Business, Innovation & Skills (BIS) has completed the Focus on Enforcement (FoE) review of the pharmaceutical sector and have reported on how well rules governing the sector are applied, delivered and enforced.
ICH: M7 Guidline reaches Step 4
The ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk has reached Step 4 of the ICH process and is now entering the implementation period (Step 5). The final draft isbeing recommended for adoption to the regulatory bodies of the European Union, Japan and the USA.
EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines.
Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.
Regulatory News
News for regulatory professionals, covering the latest from regulators, new and proposed legislation, research and studies, regulatory trends affecting the healthcare product industries, international standards and more.
EMA Pharmacovigilance System Manual
The EMA pharmacovigilance system is described in this manual, which covers the EMA organisational
structure, responsibilities, procedures, processes and resources, appropriate resource management,
compliance management and record management.
U.S. Food and Drug Administration
Updates on information about food, drugs, vaccines, medical devices and products, animal and veterinary issues, and cosmetics.
Product Division
