As already reported, the EMA has started listing so-called GMP Non Compliance Statements in the EudraGMDP database in addition to Certificates of GMP Compliance. Now, detailed information has been made publicly available. Read more in the News.
Errors when compiling an application for authorisation for a generic drug in the United States can be really expensive. It is not only important to ensure the completeness of the documents, but also to pay attention to deadlines with regard to various fees. Learn more here.
Since the 1st of January 2010, only electronical submissions for marketing authorisations within the centralised procedure can be accepted. A few significant details about the procedure and the standards have been recently changed. Read more here about the current requirements for the electronical submission of dossiers.
The Active Substance Master File (ASMF) describes the quality of an API and is an essential document for the marketing authorisation of medicinal products. The procedure to submit an ASMF has been recently updated and described extensively in a new EMA Q&A document. Read more about the newest provisions.
Besides other publications, the European QP Association (EQPA) regularly issues questions and answers related to the role and responsibilities of the Qualified Person (QP). Now, after the last QP Forum, a new set of Q&As has been published. Read more.
The USP has published a so called stimuli article which is intended to provide a proposal to revise an existing USP monograph. The proposal intends to broaden the permitted range when appropriate for specific products. Read more in our GMP News
Manufacturing of Radiopharmaceuticals includes some specific challenges. To provide additional guidance for these establishments, the PIC/S Committee's new Annex 3 to PE 010-3 is in the final stages for adoption. Read more here.