GMP NEWS 2013

Why is GMP so important? This question is answered by the FDA in an article on facts about cGMPs. The FDA gives the answers in a compact form in 6 paragraphs on two pages. Read more.

The US FDA seeks getting on the list of so called third countries and has therefore filed a listing request. Find out more.

A new ICH draft guideline on genotoxic impurities in APIs and medicinal products should help compensate shortcomings in existing regulations on the topic. The requirements of this guideline also concern medicinal products which are already available on the market. Read more here.

Until today, there was no no authorised vaccine available in the European Union (EU) for bacterial meningitis caused by Neisseria meningitidis group B. Now, the CHMP provided a recommendation for such a vaccine for the first time. Read more here.

The National Institute for Biological Standards and Control (NIBSC), currently part of the Health Protection Agency (HPA), will officially become a new 'centre' of the Medicines and Healthcare products Regulatory Agency (MHRA) alongside the Clinical Practice Research Datalink (CPRD). More details can be found here.

The EU Commission has published a draft guideline on Good Distribution Practices for APIs. The GDP regulations for distributors and distributing companies partly contain very strict requirements. Read more here.

India wants to open its first drug inspection office in Beijing, China on 01 March 2013. Read more.

In the European pharmaceutical legislation, requirements are outlined for particulars and documents that should accompany an application for marketing authorisation of a biological medicinal product. This includes information related to starting and raw materials. The draft reflection paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products i supposed to provide information on that topic. Read more here.

When medicinal products prepared from human blood or plasma are administered, infectious diseases due to the transmission of infective agents cannot be totally excluded. The "Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products" updates the previous recommendations and states the warning to be included in the SmPC and Package Leaflet of any plasma-derived medicinal product. More details can be found here.