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Hong Kong's new efficiencies in regulatory approvals for clinical trials

Jun. 22, 2017

In order to ensure the quality of clinical trials conducted in Hong Kong, a certificate of permission must be received before conducting any clinical trials there.

All clinical trials conducted in Hong Kong must :

Comply with the Guideline for Good Clinical Practice (GCP)

  • The GCP was developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It is an ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials in which people participate. It ensures the rights, safety and well-being of participants.

Observe the principles of the Declaration of Helsinki

  • The Declaration of Helsinki is a formal statement of ethical principles. It was adopted by the World Medical Association in June 1964 to guide the protection of human participants in medical research.

Possess credible data compliant with ICH-GCP guidelines

  • At the time of the product's registration, it is important to ensure the integrity of the data obtained. Submitted clinical trial information that does not comply with ICH-GCP guidelines will be rejected.

New legislation for improved regulatory efficiencies

Recognizing that procedures may be overly stringent, the Hong Kong government implemented two new pieces of legislation on the February 6, 2015.

The purpose was to make its regulatory process for clinical trials as efficient as possible while maintaining the highest safety standards.

Investigational drug samples no longer required for application

Before this piece of legislation was implemented, those who wished to conduct clinical trials had to submit investigational drug samples as part of the clinical trial application to acquire an import license. Eliminating this step significantly reduced the time required to complete the application process.

Extension of the validity of regulatory approvals

In the past, two years was the maximum length of official approval a company received to conduct clinical trials. This period has now been extended to five years, so that companies no longer have to resubmit applications in order to complete clinical trials, which usually take between two and five years.

Extending the period of validity has also given Hong Kong an international competitive edge in the field of clinical trials: Malaysia offers a validity period of only three years, and in Taiwan import licenses are valid for three years.

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