1. New Q&A on safety features concerning falsified medicines

    Following the Commission Report on Member State penalties for falsification (we reported) the European Commission has released a Questions and Answers document alongside this topic (Version 9) on 13 February 2018. The document addresses an overall of 90 frequently asked questions regarding the implementation of the rules on the safety features for medicinal products for human use. These rules are enshrined in Articles 47a, 54(o) and 54a of Directive 2001/83/EC, and in the Commission Delegated Regulation (EU) No 2016/161. They will become mandatory in February 2019.

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  2. LOGFILE No. 06/2018 – Root Cause Analysis – An Essential Enabler

    Root Cause Analysis – An Essential Enabler

    An excerpt from the GMP Compliance Adviser, Chapter 20.E Failure Management

    8 minutes reading time

    by Martin Mayer

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  3. EC: Report on Transposition of Falsified Medicines Directive

    The European Commission (EC) has published a report that takes a closer look at the implementation of the Falsified Medicines Directive 2011/62/EU in the European member states which

    • introduces mandatory safety features on prescription medicines from February 2019 on
    • strengthens good distribution practices and requirements for wholesale distributors
    • reinforces rules on importation, controls and inspections of active substances and their manufacturers, and
    • established an EU-wide logo to allow the identification of legal online retailers of medicines (as of 1 July 2015).
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  4. UK and China Sign Memorandum of Understanding

    The British MHRA (Medicines and Healthcare products Regulatory Agency) and the China Food and Drug Administration (CFDA) signed a Memorandum of Understanding (MoU) on 1 February 2018.

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  5. LOGFILE No. 05/2018 – Implementing and Monitoring Data Integrity Measures

    Implementing and Monitoring Data Integrity Measures

    An excerpt from the GMP Focus PDF Download Data Integrity in the EU

    5 minutes reading time

    by Markus Veit, PhD

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  6. EC/EMA: New Guidelines on ATMPs

    The European Medicines Agency released two updated documents for ATMPs (Advanced Therapy Medicinal Products) on 1 February 2018:

    Both documents are part of the joint action plan announced by EMA and the European Commission in October 2017 to bolster the development of advanced therapies.

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    • GMP Compliance Adviser Update No. 1/2018

      With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

      GMP Regulations

      C.6.1.1 Annex 1 – Draft: Manufacture of Sterile Medicinal Products
      C.22 Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
      D.26 Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination

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    • LOGFILE No. 04/2018 – Key learnings from serialisation projects – Part 2

      Key learnings from serialisation projects – Part 2

      6 minutes reading time

      by Andrew Love and Stephen McIndoe

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    • EMA: Survey for Pharma Companies on Brexit-Preparedness

      The European Medicines Agency (EMA) has launched a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health.

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    • MHRA: No Sudden Changes to Regulatory Framework

      The MHRA (Medicines and Healthcare products Regulatory Agency, UK) has published an update on the negotiations between the EU and the UK which have now entered the second phase.

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