GMP NEWS 2011

In a 46 page report, the Swedish Medical Products Agency (MPA) presents an initiative aiming to introduce environmental constraints into the EU GMP Guidelines. The reason for this is based on the near inexistence of environmental concerns in the countries where the manufacture of APIs is outsourced. Read more here about this initiative.

The European Medicine Agency publishes answers to frequently asked questions after they are discussed and agreed to by the GMP/GDP Inspectors Working Group. In April 2011 the Agency published the following statement. Go here to read more.

The EU Commission has published a new Draft Guideline on Good Distribution Practice. This new takes into consideration the regulations of the Directive on Falsified Medicines and should replace the existing regulations which have been valid since 1994. What this implies for the pharmaceutical wholesale can be read here.

The WHO Notice of Concern are very similar to FDA Warning Letters. These letters will be issued  to a manufacturer, contract research organization or quality control laboratory, by the WHO Prequalification of Medicines Programme. Read more about the two new Notice of Concerns here

The Certification Scheme for pharmaceutical excipients elaborated by IPEC Americas, IPEC Europe and three further European partner associations contains standards for Good Manufacturing and Distributing Practices as well as requirements for 3rd party audit organisations and their auditors qualification. Learn more about the programme here.

On 1 July 2011 the Falsified Medicines Directive (2011/62EU) has been published in the Official Journal of the European Union. Now the countdown has started for the transposition of the Directive into national law by the EU Member States and for the adoption of Guidelines for APIs and pharmaceutical excipients by the EU Commission. Please read here more about the comprehensive legislation changes to come.

The Regulatory and Procedural Guideline of the European Medicines Agency (EMA) on Certificates of Medicinal products - Instructions on how to fill the Application Form has been adopted. Read more.

The Danish Medicines Agency (DMA) recently changed its practice to pre-approve contract manufacturers and contract laboratories acceptors. Read more.

A drug and a device, a drug and a biological, a biological and a device, or maybe even all three can create a combination product. But what regulation is applicable for those products? Which new Guidance documents will be published soon? Please read more about this development in a very detailed article provided by the IPQ - one of the most important Journals in the GMP and regulatory environment. Read on here.