Implementation of PIC/S GMP Requirements
for Registration of Imported Pharmaceutical Products
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According to the recommendation of the Review Committee on Regulation of Pharmaceutical Products, the Hong Kong Good Manufacturing Practice (GMP) standards should be upgraded to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards to be on par with the international best practice. In August 2013, the Pharmacy and Poisons Board (the Board) lodged a membership application to PIC/S. It is anticipated that Hong Kong will be the 47th member of PIC/S at the beginning of 2016.
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Consequentially, the registration requirements of pharmaceutical products manufactured in Hong Kong or overseas should be complied with PIC/S standards. In September 2015, the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee (the Committee) under the Board considered the captioned subject, and decided to implement the PIC/S GMP requirements for registration of imported pharmaceutical products according to the following timeline:
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(a) New applications for registration of pharmaceutical products (received before 1 January 2016)
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For all the new applications for registration of pharmaceutical products received before 1 January 2016 but have not been completed for registration before 1 January 2017, the applicants will be required to provide evidence that the manufacturers comply with the PIC/S GMP standards before the approval of the applications.
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(b) New applications for registration of pharmaceutical products (received on or after 1 January 2016)
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With effect from 1 January 2016, all the new applications for registration of pharmaceutical products must include evidence that the manufacturers comply with the PIC/S GMP standards. Otherwise, the applications will not be accepted for evaluation.
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(c) Renewal applications of registered pharmaceutical products
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With effect from 1 January 2017, all the renewal applications for registration of pharmaceutical products must include evidence that the manufacturers comply with the PIC/S GMP standards. Otherwise, the products will not be renewed for registration.
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Ends / Friday, October 16, 2015
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