Pharmacy and Poisons (Amendment) Ordinance 2020 to Regulate Advanced Therapy Products
The Pharmacy and Poisons (Amendment) Ordinance 2020 was passed and published in the Gazette on 24th July 2020.
The Ordinance regulates the Advanced Therapy Products (ATPs) which are medical products based on genes, cells and tissues.
We attach the followings for your information:
- Letter from Department of Health to HKMHDIA:- "DH Letter_MHDIA_20200724"
- "Pharmacy and Poisons (Amendment) Ordinance 2020 es12020243019", please refer to webpage: https://www.gld.gov.hk/egazette/pdf/20202430/es12020243019.pdf
- "Guidance_for_Cell_and_Tissue_Products", please refer to webpage: http://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/atp_regulation.html
In order to allow various stakeholders to better understand the new regulatory framework for ATPs, the draft guidance documents are open for comments till 31th December 2020.
We encourage our Members to provide comments or feedback to us at firstname.lastname@example.org, we will consolidate all the comments and submit to DOH.