Guideline on the European Drug Master File Procedure updated


Guideline on the European Drug Master File Procedure updated,S-RGL_n.html

The “Guideline on Active Substance Master File Procedure” which was developed by EMA’s Quality Woring Party, describes the procedure that can be used to document an API’s quality for a regulatory authority. This guideline was already revised several times since it was initially issued in 2006. The last update was published in October 2012. This 3rd revision was updated again now to “support the Working Group on Active Substance Master File Procedures in their initiatives to improve the ASMF procedure across the European Regulatory Network” as mentioned in the remarks on page 2 of the Guideline.

The Guideline comprises updates mainly referring to its Annexes:

  • Annex 1: In part 3.2.S.2.1 of the ASMF all sites where manufacturings steps (e.g. the manufacturing of intermediates, quality controls, in-process controls, milling and sterilisation processes) take place have to be indicated.
  • Annex 2: With this Letter of Access the API manufacturer (ASMF Holder) grants the authority insight into the ASMF’s restricted part. According to the respective passage which was included in the letter template, the API manufacturer agrees that the authority exchanges the ASMF evaluation reports with the EDQM’s certification department.
  • Annex 3: This “Submission Letter and Administrative Details for documents relating to an ASMF” has to be submitted together with the ASMF as part of a new marketing authorisation application or a variation. The updated template of this letter comprises much more detailed requirements. For instance, the active substance (where applicable) has to be specified regarding its salt form, water content and grade.
  • Annex 4: Withdrawal of Access Letter. With this letter the ASMF Holder can withdraw the authorisation for the authority to use the ASMF (restricted part). The reasons for this can be the termination of API manufacture or the replacement of the ASMF procedure by the CEP procedure (CEP = Certificate of Suitability). This Annex is new.
  • The Annexes 5, 6 and 7 (previously Annexes 4 and 5) were modified only slightly. The glossary (Annex 7) includes references to the respective VICH GL39-Guideline which is based on ICH Q6A.

The Guideline text itself was adapted according to the updated Annexes.

Please see the “Guideline on Active Substance Master File Procedure”; CHMP/QWP/227/02 Rev 3/Corr” for more detailed information.



DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries...... , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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