Regulatory Roundup: Week of July 23, 2012

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A roundup of industry regulatory news.

FDA has released, Guidance for Industry, Q8, Q9, & Q10 Questions and Answers, Appendix Q&As from Training Sessions. The document, prepared by the International Conference on Harmonisation's (ICH) Quality Implementation Working Group, presents points to consider in relation to the implementation of ICH Q8(R2), Q9, and Q10. The guidance is based on questions asked during training workshop sessions in three regions and is not intended to be a new guidance. The guidance was written to provide clarity on the quality-by-design (QbD) approach. Topics discussed in the guidance include process validation, design space, and models in QbD.

Commissioner Margaret A. Hamburg announced on July 23 that FDA has approved or tentatively approved 152 antiretroviral drugs to treat HIV and AIDS patients through President’s Emergency Plan for AIDS Relief (PEPFAR). Among the tentative approvals given by FDA in association with PEPFAR were to the generic drugs abacavir oral solution (Hetero Labs Ltd.), lopinavir and ritonavir oral solution (Cipla Ltd.), and efavirenz tablets (Edict Pharmaceuticals Private Ltd.). Giving a drug tentative approval in association with PEPFAR, according to an FDA press release, means that although FDA has found that a drug product has met all required requirements, it cannot be approved for marketing in the US because of existing patents or marketing exclusivity. The product is, however, eligible for purchase in foreign markets through the PEPFAR program. FDA expedites all reviews of drug applications and inspections of the overseas facilities received in association with PEPFAR. “PEPFAR is driven by a shared, global responsibility to save lives affected by HIV and AIDS,” said Commissioner Hamburg, M.D., in the press release. “Thanks to the hard work and commitment of hundreds of FDA staff and our partners, we now have safe and effective antiretroviral drugs that are widely available at low cost and in forms that allow for better adherence. Together, we are changing the course of the AIDS epidemic.”


The European Medicines Agency (EMA) has released prevalence data for orphan conditions on its website.  The table includes sources previously assessed and accepted by the Committee for Orphan Medicinal Products. EMA decided to make the data, which have been collected over the past 10 years, public to encourage development of rare disease drug products and facilitation the orphan designation process, according to an EMA press release. The table will be updated on a regular basis by EMA.