Macau, China: Instrução Técnica sobre Documentos Necessários para Importação de Novos Produtos Farmacêuticos

 

In Macao, a new Technical Instruction on Documents Required for Importing New Pharmaceuticals was published.

It prescribes the documents that shall be submitted by pharmaceutical importers/exporters and wholesalers when applying for import of pharmaceuticals containing new active pharmaceutical ingredients.

Pharmaceutical import and export companies requesting the import of medicines containing new active pharmaceutical ingredients are required to submit the following documents:

1) Documents of mandatory presentation for the importation of medicines, contained in Technical Instructions No. 2/2000, issued by the Director of Health Services on 23 November 2000;

2) Official document or certified copy of registration and free sale of the drug in any of the following countries or regions: Mainland China, Australia, Canada, European Union, United States of America, Japan, United Kingdom and Switzerland;

3) Professional study report on the safety, therapeutic effect and quality of the drug;

4) Electronic file of clinical trial report on Asian subjects or report of application experience in Asian countries or regions;

5) European Union risk management plan, United States Food and Drug Administration risk mitigation strategies or respective risk management strategy documents.