Current news

  1. FDA Warning Letters go to Manufacturers in China, Ireland, Australia and India

    In May the US FDA has issued five Warning Letters that address cGMP-violations on a large scale. The drug facilities involved are:

    • Jilin Shulan Synthetic Pharmaceutical und Nox Bellcow Cosmetics Co, China
    • Jalco Cosmetics, Australia
    • Europharma Concepts, Ireland
    • Reine Lifescience, India.

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  2. EMA: Draft Guideline on Handling and Shipping of IMPs according to GMP

    On 23 May 2018, the European Medicines Agency (EMA) released a guideline laying out the principles for managing investigational medicinal products for use in a clinical trial and in accordance with Good Clinical Practices (GCPs) and Good Manufacturing Practice (GMPs) for public consultation.

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  3. Post-Brexit Agreement for UK's Pharmaceutical Industry Needed

    The UK government must secure a post-Brexit deal for the pharmaceutical industry that ensures the closest possible regulatory alignment with the EU and the minimum border friction possible or risk harming patients and seeing the pharma sector losing its status as a world leader, say the Business, Energy and Industrial Strategy Committee of the UK parliament.

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  4. Danish-Japanese collaboration – FDA Confidentiality Commitment

    The Danish Medicines Agency recently met with representatives from the Japanese Ministry of Health, Labour and Welfare (MHLW), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in Copenhagen.

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  5. PIC/S Meeting in April 2018

    From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.

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  6. Finally: EMA’s Q&A on Health-Based Exposure Limits was published

    On 30 April 2018, the EMA published the final, revised version of the Q&A document with its focus on setting health-based exposure limits for risk identification and the risk-based prevention of cross-contamination. The Q&A covers 13 questions and answers relating to the “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”, which has been in force since June 2015.

    In January 2017, the EMA released a draft for public consultation (we reported). But this paper constituted a roll backwards!

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  7. EMA and the Netherlands agree on Seat Agreement

    The European Medicines Agency (EMA) and the Netherlands have finalised the text of a Seat Agreement which describes how the Agency, its bodies and its employees will be treated by the Dutch once they start operating in the Netherlands.

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  8. MHRA five-year Corporate Plan 2018-2023

    On Tuesday, 27/4/2018, MHRA (Medicines and Healthcare products Regulatory Agency) published is five-year Corporate Plan for 2018 - 2023.

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  9. ICH Q3C(R7) Guideline for Residual Solvent in Step 1

    Almost one year ago, the ICH published its Guideline for Residual Solvents in the version ICH Q3C (R6) introducing new PDE-Levels for Triethylamine and Methylisobutylketone.
    Currently, this Guideline is again undergoing maintenance, which shall result in the future Q3C(R7) version, to develop PDE levels for the following three solvents:

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  10. FDA Finalises ICH Q7 "Q&A on GMPs for APIs"

    The FDA (US Food and Drug Administration) finalised the ICH Q7 Q&A Guidance on GMPs for APIs on Thursday April 19, 2018.

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