NSF-DBA News & Tech Talk

Brokers - EU Falsified Medicines Directive requirements

Mon, 13 May 2013 00:00:00 +0100

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), and
Where the medicinal product is obtained through brokering, the wholesale distribution authorisation holder must verify that the broker involved fulfils the requirements set out in this Directive. (Article 80)

The UK MHRA has confirmed that this means that companies in the EU cannot use brokers located outside of the EU/EEA. This is likely to present difficulties for many organisations as, for example, they often use brokers in countries like Switzerland to buy and sell product and ingredients for tax reasons. This will no longer be possible.

QP’s Declaration of GMP Compliance for Investigational Medical Products

Fri, 03 May 2013 13:00:37 +0100

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 either (i) an audit by the QP, where you have to say who the ‘auditing party’ was and the date of the last audit; or (ii) if the manufacturing site has not been audited, a justification as to how the QP knows that the site meets EU GMP.

NSF International Acquires IPEA

Tue, 30 Apr 2013 14:10:11 +0100

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 excipient manufacturers and distributors – has approved the sale of its IPEA auditing subsidiary to NSF International. The transaction is expected to be finalized in spring 2013 and will position NSF International as a leader in the excipient auditing arena and will enable NSF to develop new service offerings and deliver excipient, food additive and dietary supplement ingredient audits together.

Importation of APIs into the EU

Tue, 30 Apr 2013 00:00:00 +0100

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 TGA.

Australia has just 5 of the 1560 sites globally exporting to the EU (0.3%).

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

Mon, 29 Apr 2013 14:08:08 +0100

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 Drug Quality Initiative

FDASIA has 150 specific requirements for FDA, including 19 Regulations, 24 Guidances, and 14 reports to Congress. GDUFA aims to bring down the review cycle for Generic Drugs to a 10 month review cycle by year 5. The new OGD ‘Super’ Office will move to the White Oak campus next year.

FDA are also working towards standardizing approaches for drugs requiring REMS programs of monitoring.

In the Biosimilars area, FDA is currently dealing with 55 requests related to 12 reference products. 16 are at the IND phase.

CDER’s Quality Initiative is moving forward internally after the formation of the Council of Pharmaceutical Quality two years ago.

FDA believe that further modernization to the regulation of Drug Quality and Surveillance is needed. FDASIA gives them the required authority and resources.

FDA will be seeking a more level playing field and standards for drugs from all sources – R&D, Generic, and OTC. As part of this, FDA are also looking at the use of standard metrics for measuring manufacturing qualilty.