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Regulatory Roundup, Week of November 26, 2012
EMA addresses drug supply shortage.
The European Medicines Agency (EMA) has announced a plan to address drug supply shortages following manufacturing problems. The plan was developed in collaboration with the European regulatory authorities in the EU member states.
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has provided an update from the Pharmacopoeial Discussion Group (European Pharmacopoeia, Japanese Pharmacopoeia, and the US Pharmacopeia) meeting that took place on Nov. 6–7, 2012 in Rockville, Maryland. According to EDQM, 28 of the 35 General Chapters and 43 of the 62 excipient monographs have been harmonized.
The International Conference on Harmonization (ICH) has released an update from the Steering Committee and its Expert Working Groups meeting in San Diego, California, on Nov. 10–15, 2012. The meeting addressed reform to include the involvement of global regulators and reassure ICH’s commitment to harmonization.
FDA has released the following guidance documents and guidelines:
- Vaginal Microbicides: Development for the Prevention of HIV Infection, Draft Guidance, Center for Drug Evaluation and Research (CDER), November 2012.
- Processing Requests for the Review of Grouped Supplements, Policy and Procedures, Office of Generic Drugs, CDER, Nov. 20, 2012.
