Monday the 8th April 2013
On 5 April 2013 the Commission published version 4 of their Q&A regarding the importation of APIs from outside of the EU. This version contained 3 new questions and answers:
- Question 2a asks “Does the written confirmation apply to blood plasma?” The answer is “no”. However, substances isola...
Thursday the 4th April 2013
In April 2013 the FDA released a draft guidance of scale-up and post-approval changes that combines and supersedes the following previous SUPAC guidance documents:
- SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum
- and SUPAC-SS No...
Wednesday the 13th March 2013
One of the big challenges of slowing the flow of counterfeit drugs is its international nature. Fakes may be made in China, for example, and make stops in several continents before finding their way into the legitimate supply chain. In that regard, the international policing agency Interpol is w... Read more
Monday the 11th March 2013
The EU published the final version of their revised Good Distribution Practices (GDP) guideline on Friday 8 March. At first glance this final version looks very similar to the draft that was published in 2011.
The revised guidelines introduce the following changes:
- The maintenance of a qua...
Monday the 25th February 2013
An ‘Agreement on Conformity Assessment and Acceptance of Industrial Products’ (ACCA) between the European Union and Israel came into effect on 4 January 2013.
The ACAA applies to medicinal products for human and veterinary use including chemical, biological, immunological, radio-pharmaceutica... Read more