The long awaited EU GDP Guidelines was published in the Official Journal of the European Union by EU Commission on 7 March 2013. This document will replace the current GDP Guideline published in 1994 (94/C 63/03). Click here to read more.
The Chinese Ministry of Heath (MOH) published on 22 January 2013 new requirements on Good Distribution - respectively on Good Supply Practice for Pharmaceutical Products. The new regulations apply not only to distributors but also to pharmaceutical manufacturers. Read more here.
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.
Strict requirements have to be complied with when submitting a dossier for the application of a new CEP. Read more about the changes recently published in a revised Policy of the EDQM on restrictions regarding substances.
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 heads of the EU authorities for medicines are organised in a group called Heads of Medicines Agencies. In a meeting which took place in Dublin just recently, the Committee identified the need for GMP inspections to be conducted at API manufacturing sites by the 2nd of July 2013. Read more.
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 issue manual versus fully automatic inspection with regard to a 100% visual inspection of parenterals is a frequently discussed GMP issue. Please find a list of Q&As on this subject in our GMP News Read more.
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.
The EU Commission has recently published an extended Question and Answer Document on APIs importation into the EU and the "Written Confirmation". In addition, an up-to-date version of the "Written Confirmation" form has been released. Read more here about the changes made in both documents.
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.
In 2012, the EMA Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products was open for comments. The risk-based approach is based on the identification of various risks associated with the clinical use of an ATMP and risk factors inherent to the ATMP with respect to quality, safety and efficacy. To learn more about this, click 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.
In Febraury 2012 EMA's "Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture" became official. The scope of this document is to provide guidance for the isolation on cell culture of any potential influenza vaccine virus intended for cell culture or egg-based influenza vaccine manufacture. More details can be found here.
In February 2012 the "Guideline on clinical investigation of recombinant and human plasma-derived factor IX products" came into effect. The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation for recombinant or plasma-derived factor IX products. More can be found here.