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quarta-feira, 24 de março de 2021

PIC/S 2021 work plan: complete the negotiation of China’s membership and revise a large number of guidelines

Original Knowing the Forest-Pepper Knowing the Forest Yesterday

 The International Pharmaceutical Certification Cooperation (PIC/S) released its 2021 work plan on March 15.  Some of its 2021 work plan is due to the unfulfilled goals of the new crown (COVID-19) in 2020.  In addition, PIC/S stated in its work plan that the completion of the accession negotiations with China's NMPA will be a priority.  [2020 work plan of China and PICS 2020/01/15]

 The Brazilian regulatory agency (ANVISA) joined PIC/S as the 54th participating agency on January 1 this year.  In addition, PIC/S will evaluate the regulatory agencies of Armenia, Azerbaijan, Bangladesh, Bulgaria, Pakistan, Russia, and Saudi Arabia that have applied for accession or pre-accession in 2021.  In addition, participating institutions in Chinese Taipei, Indonesia, New Zealand, and South Africa will be reassessed.

 All assessments and reassessments will be coordinated and supervised by the PIC/S Compliance Subcommittee (SCC).  SCC will consider implementing a desktop reassessment process and will also establish a list of experienced auditors who will provide assistance and advice to the rapporteurs and auditors.

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