Designating API starting materials acceptably in a chemical synthesis

mikerobe's blog

Making the correct designations of ‘active substance starting materials’ in a chemical synthesis can be very difficult but is extremely important to your company.  There is a subjective element to overcome and only a limited set of rules to help you with the decisions.  These will be discussed and some examples considered in our comprehensive CTD Module 3 course in London on 2 – 3 July 2013.

The impact of the designations on GMP compliance with regard to development costs and to the time taken to gain regulatory approvals of Marketing Authorisation applications can be huge, so increasing your understanding of the many issues is more than sensible!  Please hurry to book if you want to secure a place.  Bookings close soon.

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EMA releases draft policy for clinical trial data transparency

June 25 2013 | By Márcio Barra

The European Medicines Agency (EMA) has just released for consultation a draft policy on access and transparency of clinical-trial data. This draft details three levels of access according to the type of data, alongside rules for publication and use.

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Supervision of Chinese-Made Drug Substances by Philippe André

New Drug Approvals

Why source drug substances from China?
Large markets, economies of scale and cheaper labor;An industrial ecosystem supplying raw materials and equipment;Developed infrastructure and industry friendly policies;About 5,000 manufacturers;

Thousands of chemists and students across China looking for novel synthesis routes for generic drug substances and intermediates.

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Genotoxic Impurities In Pharmaceuticals

Decisions to approve, prescribe and consume medicines involve risk/benefit assessments by regulatory agencies, health care professionals and consumers. For serious or life threatening conditions, drugs with higher risks for adverse effects or for serious adverse effects are sometimes acceptable. For example, some life-saving cancer chemotherapies are known human carcinogens. However, if one is suffering from a life threatening tumor, a 5% risk of a secondary, treatment-related tumor is generally considered acceptable. Arguably, the same is not true for impurities found in drug substances and drug products; impurities convey only risk with no associated benefit. Drug impurities might be viewed as “pollutants” in the pharmaceutical world. Much like pollutants in the environment, few people believe that they can be entirely eliminated. The challenge for regulatory agencies is to promulgate standards that assure that unavoidable drug impurities impart no or acceptable levels of risk.

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Tecfidera’s impressive launch hit by supply and reiumbursement problems

June 20 2013 | By Márcio Barrahm duno

Tecfidera, Biogen’s idec of first-line oral treatment for people with relapsing forms of Multiple Sclerosis  approved back in March in the US and EU, is having a very impressive start, selling so well that it’s expected to break the blockbuster barrier by next year according to the The Wall Street Journal. But the demand is such among patients, doctors and pharmacies that supply hasn’t been able to fully satisfy the demand.  Supply chain and manufacturing snags also interfered with distribution, said Biogen’s CEO George Scangos.

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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.

FDA’s Portal To India

Regulatory Compliance Digest

SacksOfSpicesA cursory look in our kitchens confirms the fact that it is indeed a small world after all.  Those of us living in the U.S. take know that as part of our daily routines, including the foods we consume.  India is a case in point.

According to the U.S. Commerce Department, nearly one quarter of the spices, oils and food colorings used in the U.S. comes from India.  Overall, in 2011, India was the second largest drug exporter and the seventh largest food exporter to the U.S.

It makes sense then that a high-level U.S. agency plays a prominent role in coordinating the interests of Americans in this ever-expanding global village.  As part of its broader regulatory functions, the U.S. Food and Drug Administration (FDA) works to ensure that foreign-produced foods and drugs are safe, effective and of good quality.

FDA Collaboration with India

As part of its response…

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