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

Letter from WHO July 2016

Dear colleagues,

 

We would like to inform you that a public consultation on several documents for the WHO Expert Committee on Biological Standardization (ECBS) is now open.

 

Based on WHO consultations with regulators, manufacturers and other experts the following documents were prepared and have been posted on the WHO biologicals web site http://www.who.int/biologicals/en/

for public comments:

 

  1. BS 2279 – Guidelines on the quality, safety and efficacy of Ebola vaccines (proposed new guidelines)

http://www.who.int/biologicals/Ebola_Guidelines_BS.2016_2279_TZ_5_July_2016.pdf?ua=1

Comment form: pdf Guidelines on the quality, safety and efficacy of Ebola vaccines (175 KB)

Comments should be sent to the Responsible Officer: Dr Tiequn Zhou at email: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

  1. BS 2280 – Labelling information of inactivated influenza vaccines for use in pregnant women

http://www.who.int/biologicals/BS2280_MI_Flu_LINE_NOs_14_July_2016.pdf?ua=1

Comment form: pdf Labelling information of inactivated influenza vaccines for use in pregnant women: WHO/BS/2016.2280 (21 KB)

Comments should be sent to the Responsible Officer: Dr Hye-Na Kang at email: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

  1. BS 2287 – Guidelines on clinical evaluation of vaccines: regulatory expectations

http://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1

Comment form: pdf Guidelines on clinical evaluation of vaccines: regulatory expectations (BS2016.2287) (275 KB)

Comments should be sent to the Responsible Officer: Dr Ivana Knezevic at email: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

  1. BS 2289 - Guidelines on regulatory preparedness for licensing human pandemic influenza vaccines in non-vaccine-producing countries

http://www.who.int/biologicals/BS2289_PIP_non-producer_guide_LINE_NOs.pdf?ua=1

Comment form: pdf Guidelines on regulatory preparedness for licensing human pandemic influenza vaccines in non-vaccine-producing countries (BS2016.2289) (29 KB)

Comments should be sent to the Responsible Officer: Dr Dianliang Lei at email: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

  1. BS 2290 – Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs)

http://www.who.int/biologicals/BS2290_mAb-SBP_DB_Kai_LINE_NOs_20_July_2016.pdf?ua=1

Comment form: pdf Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs) WHO/BS/2016.2290 (15 KB)

 

We would be grateful if you could provide feedback in your capacity as a member of the Expert Advisory Panel on Biological Standardization and other relevant Panels. Also, please share this information with your colleagues who may be interested in the topics mentioned above.

All comments received by published deadlines on the website will be considered in the preparation of the discussion at the ECBS meeting to be held from 17 to 21 October 2016.

Thank you.

With best regards,

Ivana

 

International Alliance for Biological Standardization


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