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    PIC/S finalizes GMP data integrity guidance

    This week, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced that its new guidance on good practices for data management and integrity for pharmaceutical manufacturers and distributors has come into effect.   When authorities inspect facilities of manufacturers and distributors of active pharmaceutical ingredients to ensure good manufacturing practice and good distribution practice (GMP/GDP) compliance, “The effectiveness of these inspection processes...
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    PIC/S looks to adopt EU Annex on qualified persons, batch release

    The Pharmaceutical Inspection Cooperation Scheme (PIC/S) this week announced plans to incorporate the EU good manufacturing practice (GMP) Annex 16 on batch release by a qualified person (QP) into a PIC/S guideline. The aim is to have non-EU/European Economic Area (EEA) members incorporate Annex 16 into their regulatory systems.   The EU’s Annex 16 covers the certification of a QP that can release product batches for marketing authorization holders in the EU or labeled...
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    PIC/S updates GMPs for ATMPs, biological substances

    Revisions to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide addressing the manufacturing of advanced therapy medicinal products (ATMPs) as well as biological medicinal substances and products are set to go into effect 1 May.   PIC/S published the final Annex 2A and Annex 2B on 23 April after a consultation that began in September 2019. (RELATED: PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances , Regulatory Focus, ...
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    PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is seeking comments on revisions to two parts of its GMP Guide (Annex 2A and Annex 2B) that deal with the manufacture of advanced therapy medicinal products (ATMPs) and biological medicinal substances and products for human use. PIC/S explains that draft Annex 2A accounts for international developments in the regulation of ATMPs, with particular attention to the European Commission guideline on GMP for ATMPs, whi...
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    PIC/S Drafts Guidance on Good Practices for Data Management and Integrity

    As data integrity violations continue to be found in Form 483s and warning letters, the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme (PIC/S) released a 52-page draft guidance outlining how an inspector should inspect facilities that must adhere to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. The guidance, which will be open for consultation until 28 February 2019, was directed by the Australian an...
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    Asia Regulatory Roundup: CFDA Seeks to Exempt More Devices From Clinical Trials (23 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Abbott, Novartis and Sanofi Targeted in NPPA Clampdown on Drugs Sold Without Price Approval The National Pharmaceutical Pricing Authority (NPPA) of India is taking action against drugmakers including Abbott, GlaxoSmithKline, Novartis and Sanofi. NPPA included the top pharmaceutical firms on a list of companies that allegedly introduced drugs without seeking price appro...
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    FDA Seeks Input on Device Accreditation Pilot

    The US Food and Drug Administration (FDA) on Monday asked stakeholders for input on its planned pilot program for accrediting medical device test laboratories in an effort to boost device makers' ability to rely on conformity to recognized standards to support premarket submissions. As part of the agency's negotiations with industry for reauthorizing the Medical Device User Fee Amendments (MDUFA) , FDA agreed to establish a program for accrediting test labs that evalu...
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    UK Patients to Get Early Access to AbbVie's HCV Combo

    Patients in the UK will get early access to AbbVie's experimental pan-genotypic hepatitis C (HCV) drug combination, the Medicines and Healthcare products Regulatory Agency (MHRA) announced Wednesday. The combination, known as glecaprevir/pibrentasvir, is currently undergoing an expedited review by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for its potential to treat patients across all six major genotypes of HCV, with or wi...
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    Pharmaceutical Inspection Co-operation Scheme Offers New Strategic Plan Through 2019

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week unveiled a new road map for the next two years during its February meeting in Switzerland, which was attended by representatives of 37 of its regulatory authorities. Training was cited as PIC/S’ “most important field of activity,” and following the July 2016 launch of the PIC/S Inspectorates’ Academy (PIA), the group says considerations will be made on training inspectors on the revised Annex 1 on steril...
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    Pharma Inspection Co-operation Scheme Criticizes Plan to Lower GMP Requirements for ATMPs

    The regulatory group known as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) said in a letter released this week that it is “unanimously concerned” about the public health and safety impact of a new European Commission guideline that would lower good manufacturing practice (GMP) requirements for advanced therapy medicinal products (ATMPs). "By lowering the GMP requirements for ATMPs, the European Commission is not only exposing patients to an increased risk t...
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    BMS' Opdivo Wins UK EAMS Approval for Hodgkin's Lymphoma

    The Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday accepted Bristol-Myers Squibb's Opdivo (nivolumab) to its early access to medicines scheme (EAMS) to treat relapsed or refractory Hodgkin's lymphoma. Previously, MHRA granted access to Opdivo under EAMS for patients with certain types of lung cancer, kidney cancer and melanoma. Background In March 2014, MHRA announced it was launching EAMS, saying it would allow earlier access to potentially...
  • ICH and Pharmaceutical Inspection Co-operation Scheme: No Expectations for China or India to Join

    While China and India continue to supply most of the world with pharmaceuticals (and continue to be plagued by quality and data integrity concerns), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and International Council on Harmonisation (ICH) – two of the largest international pharmaceutical regulatory schemes – say neither China nor India has any plans to join either group in the near future. Paul Hargreaves, chair of PIC/S, explained to attendees at the P...