Letter from WHO October 2016

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Sent: 10/7/2016 11:36:14 A.M. Eastern Daylight Time
Subj: PUBLIC CONSULTATION: Working document QAS/16.686: Good regulatory practices: guidelines for national regulatory authorities for medical products: request for comments by 15 December 2016

Dear Colleagues,

We would like to invite you to review the draft “GOOD REGULATORY PRACTICES: GUIDELINES FOR NATIONAL REGULATORY AUTHORITIES FOR MEDICAL PRODUCTS” which has been posted on the WHO Medicines website under Current projects (http://www.who.int/medicines/areas/quality_safety/quality_assurance/projects/en/ ), using the designated template to provide your comments. The draft guideline and commenting form are enclosed with this email for your convenience.

  pdf Guidelines - Good Regulatory Practices (1.22 MB)
  pdf Template for comments (113 KB)

The draft guideline has been developed based on the outcomes of several WHO GRP workshops and meetings and is now posted for public consultation. All comments received by 15 December 2016 will be considered in the preparation of “GOOD REGULATORY PRACTICES: GUIDELINES FOR NATIONAL REGULATORY AUTHORITIES FOR MEDICAL PRODUCTS”. The draft will also be submitted to the fifty-first meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations on 17-21 October 2016.

Please share this communication with colleagues.

With kind regards,
Daniela Decina

Technical Officer HIS/EMP/RHT/RSS
World Health Organization
Tel: +41 22 7913480

International Alliance for Biological Standardization


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