Industry news

Brokers - EU Falsified Medicines Directive requirements

With respect to brokers the FMD now requires:

• Persons brokering medicinal products shall have a permanent address and contact details in the Union so as to ensure accurate identification, location, communication and supervision of their activities by competent authorities. (Article 85b), an...

QP’s Declaration of GMP Compliance for Investigational Medical Products

On 30 April 2013 the European Commission published the final version of a ‘Template for the QP’s Declaration of GMP Compliance for IMPs manufactured in non-EU countries’ as an addition to Eudralex volume 10.

This is a simple two page template. The declaration can be made on the basis of eithe...

NSF International Acquires IPEA

International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) Approves Sale of Its IPEA Auditing Subsidiary to NSF International

The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) – an international non-profit comprised of pharmaceutical and e...

Importation of APIs into the EU

The European Commission has approved a second country to go on to their list of accepted countries (the so called ‘white list’) for the importation of APIs into the EU; Australia. This means that APIs imported from Australia into the EU will not need to be accompanied by a certificate from the ...

FDA Update: Janet Woodcock CDER, at recent FDLI event in DC

FDA CDER Director Janet Woodcock shared her views on the 3 ‘big ticket’ items currently engaging FDA at the FDLI Conference in Washington, DC on April 23rd. Janet indicated that her ‘big 3’ were:

• Implementation of FDASIA (Food and Drug Safety and Innovation Act)
• Biosimilars
• CDER’s new D...