Regulatory News - February 2018
The EMA has published the following advice/guidance documents:
- An explanatory note to GVP Module VII (PSURs) and Q&A for assessors
- Pre-authorisation procedural advice for users of the centralised procedure and post-authorisation procedural advice for users of the centralised procedure
- Revision 5 of the “Guideline on the evaluation of anticancer medicinal products in man” (effective in April 2018)
The EMA has published the following material/communication for the public:
- Three video animations (see EMA YouTube channel) to explain how the EMA ensures that medicines are effective and safe for citizens across the European Economic Area
- An updated brochure on the EU regulatory system for medicinal products that provides a high-level overview of the public
- A fact sheet on orphan medicines
- A press release regarding a defect reported with oral plastic syringes prefilled with Buccolam (epilepsy medicine for children)
Ukraine published guidance (similar to the EU GVP) on RMPs (Annex 14) and PSURs (Annex 12).
Indian regulators have published a Pharmacovigilance Guidance Document for MAHs (effective in January 2018), which has a major impact on companies in India (e.g. requirements for a pharmacovigilance system master file [PvMF], similar to the EU PSMF, and a PV officer-in-charge [PvOI], similar to the EU QPPV).
The Japanese Health Authority has instituted Conditional Early Approval System for Pharmaceuticals in October 2017, which is similar to the Accelerated Approval by the FDA and will allow early approval of drugs intended to treat serious conditions.
The final ICH guideline E17 on general principles for the planning and design of multi-regional clinical trials (effective 14 Jun 2018) is available here.
The ICH guideline Q3D on elemental impurities became effective in the EU in December 2017 for authorised medicinal products.