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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

  • Concerns Shared About ATMP GMPs

    Apr 26, 2017

    PIC/S expressed concerns about the European Commission’s proposed advanced therapy medicinal products (ATMP) GMP guidelines in a letter dated Feb. 24. In particular, PIC/S is concerned the proposed guidelines will lead to a nonharmonized approach to ATMP GMPs in addition to lowering standards for ATMP GMPs.

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  • PIC/S Releases Data Integrity Guide for Inspectors

    Oct 3, 2016

    PIC/S has released a draft data integrity guidance. This draft guidance is being made available to facilitate the effective implementation of data integrity elements into the routine planning and practice of GMP/GDP inspections. The guidance also provides support for risk-based data integrity inspections.

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  • New Agencies Join PIC/S

    Feb 10, 2016
    Effective Jan. 1, the Pharmacy and Poisons Board of Hong Kong SAR (PPBHK) and Croatia’s the Agency for Medicinal Products and Medical Devices (HALMED) joined PIC/S.
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  • PIC/S Elects New Chairman

    Dec 22, 2015
    At its October meeting in Indonesia, PIC/S elected Paul Hargreaves of the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) as Chairman for 2016–2017. New office holders were also elected for seven PIC/S subcommittees
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  • New PIC/S GMP Guide Now Available

    Oct 15, 2015

    The revised PIC/S GMP Guide became effective Oct. 1. This revision incorporates the EU’s Annex 15 revision covering qualification and validation. 

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  • PIC/S Establishes Inspectors Academy

    Nov 18, 2014

    At the PIC/S Committee meeting in Paris Oct. 20–21, the Committee established the PIC/S Inspectors Academy (PIA). This Academy—a PIC/S initiative—will feature a Web-based educational center with a focus on harmonizing and standardizing GMP training at the international level using an accredited qualification system.

    PIA should be in operation by the third quarter of 2015.

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