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Drug Registration 
 

 

Details of pharmacetical product registration:
 

 1.          Pre-work of product registration

 2.          Inspection and examination of existing product and company information

 3.          Product Registration application eg. Form filling

 4.          Verification of company documents

 5.          Verification of product documents

 6.          Product labeling and description leaflet - comply with the law in Hong Kong

 7.          Product classification based on the government requirement –formulation evidence and rationale

 8.          Selection of suitable lab for carrying out the tests; Finding certified lab for testings.eg.heavy metal, bacterial and pesticide tests

 9.          Finding professionals for formulation formation, principle and rationale, manufacturing process

 10.      Examine the qualification of manufacturer. eg. the legal documents

 11.      Obtaining the physical-chemical properties of the raw materials (or active ingredients and the formulation principle references (eg. CP).

 12.      Submission of documents to government officer.

 13.      Toxicity testing consideration

 14.      Selection of suitable lab; finding certified lab for testing including local, long term and acute toxicity testings.

 15.      Follow up the report writing from the certified lab based on the testing result. The contents include safety profile, efficacy profile and pharmacology profile

 16.      Quality and stability testing consideration

 17.      Selection of suitable lab (balancing pricing and professional manner);finding certified lab for testings

 18.      Decision on testing method selection

 19.      Follow up the report writing from the certified lab based on the testing finding.

 20.      Selection, verification, collection of product efficacy reference and , physical and chemical properties of the raw materials.

21.      Follow up the whole process with the government officer eg. re-submission, correction, verification and examination of related documents.

 

 


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