New Drug Registration Services in HONG KONG.
New drug registration is the process of obtaining a license for marketing a new drug. It is also called NDA or New Drug Application. The first step to getting new drug registration in Hong Kong is to apply to Hong Kong Department of Health (HKDA).
Once your application passes the initial assessment stage, HKDA will conduct clinical trials on your product and then make sure that it’s safe before approving it for sale in Hong Kong market.
Know about new drug registration in Hong Kong.
New drug registration in Hong Kong is the process of obtaining permission from the government to manufacture, import and sell a new medicine. The steps required for new drug registration are:
Preparation of an application form by your local agent or representative.
Submission of an application form with supporting documents to HKDA (Hong Kong Department of Health) for assessment by the Committee on Safety of Medicines (CSM).
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New Drug Registration Services in HONG KONG.
New Drug Registration Services in HONG KONG
New drug registration refers to the process of applying with the Hong Kong Department of Health (HKDA), to obtain approval for a new medicine. The DH is responsible for regulating all medicines that are sold in Hong Kong, including prescription and over-the-counter drugs and medical devices. Once your product has been approved by the DH, you may sell it in Hong Kong as long as it remains within its shelf life.
The process of pharmaceutical product registration in Hong Kong.
The process of pharmaceutical product registration in Hong Kong.
To obtain a new drug registration in Hong Kong, an applicant must submit an application form along with relevant documents and fees to the Department of Health of the HKSAR Government.
Conclusion
We offer a complete range of pharmaceutical product registration services in Hong Kong. Our team of experts is well-versed with the regulatory requirements and has years of experience in providing consultancy services to companies across the globe. If you are looking for assistance in getting your drug registered or any other related issue, contact us today!



