Tag Archives: China

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DSJ to attend GBA legal forum in Shenzhen and Global Economic Development and Security Forum of Boao Forum for Asia in Changsha

     The Deputy Secretary for Justice, Mr Cheung Kwok-kwan, will attend large-scale forums in Shenzhen and Changsha to promote Hong Kong’s status as the centre for international legal and dispute resolution services in the Asia-Pacific region.

     Tomorrow (October 27) in Shenzhen, Mr Cheung will first attend the 2023 Guangdong-Hong Kong-Macao Greater Bay Area (GBA) Legal Forum (Shenzhen), and deliver a speech on the latest initiatives on the development of the GBA in the Policy Address before returning to Hong Kong in the afternoon.

     Bringing together professionals from the political, legal and business sectors, the forum will focus on enhancing the “soft connectivity” of cross-border legal services to further support the integration of Hong Kong and Macao’s legal services into the overall development of the country and promote the deepening of co-operation in legal services.

     Next, he will depart for Changsha on October 29 for the 2nd Conference of Global Economic Development and Security Forum of the Boao Forum for Asia (BFA-GEDS). He will return to Hong Kong on October 30.

     With the theme of “Global Development and Shared Security” this year, the BFA-GEDS is an important platform for forging consensus on global economic development and security.

     Mr Cheung said that one of the key initiatives in this year’s Policy Address is to enhance the development of the “eight centres” to dovetail with national strategies for creating strong impetus for growth.

     Noting that security is the foundation of high-quality economic development, he added that the forum will facilitate delegations from Hong Kong and other places to focus on “Global Development” and “Shared Security”, and to conduct high-level, in-depth and cross-disciplinary discussions on a number of hot topics. read more

East Asia

“1+” mechanism for approval of new drugs to commence on November 1

     The Department of Health (DH) today (October 26) said that the new mechanism for registration of New Drugs (“1+” mechanism) announced in “The Chief Executive’s 2023 Policy Address” was endorsed by the Pharmacy and Poisons Board of Hong Kong (the Board) and will come into effect on November 1.
      
     The implementation of the “1+” mechanism will allow Hong Kong to be more proactive to expedite the approval of applications for registration of new drugs (i.e., pharmaceutical products containing new chemical or biological entities) for life-threatening or severely debilitating diseases and will also strengthen Hong Kong’s capacity in drug evaluation in the long run, which is an important step in progressing toward a primary evaluation approach. 
      
     Under the Pharmacy and Poisons Ordinance (Cap. 138), pharmaceutical products must satisfy the criteria of safety, efficacy and quality for registration before they can be sold or supplied in Hong Kong. According to existing requirements, generally, applicants for registration of new drugs are required to provide, among others, documentary proof for registration of pharmaceutical products issued by drug regulatory authorities from at least two reference places for rigorous evaluation before placing in the market.
      
     The DH spokesman said that under the newly established “1+” mechanism, applications for registration of new drugs beneficial for treatment of life-threatening or severely debilitating diseases that are supported with local clinical data and scope of application recognised by local relevant expert are required to submit approval from one reference drug regulatory authority (instead of the two) and could submit application for registration in Hong Kong.
      
     The DH has announced the arrangement in the relevant website, issued letter to notify the relevant stakeholders (including relevant pharmaceutical associations and holders of certificate of drug registration) to introduce the relevant details of the “1+” mechanism. For further details, please refer to the Drug Office’s website.
      
     The “1+” mechanism will facilitate the registration of new drugs from different parts of the world that meet local unmet medical needs in Hong Kong and allow patients’ early access to new drugs. The new mechanism would attract more drug development and clinical trials to be conducted in Hong Kong, and the requirements of local clinical data and recognition by relevant expert for application for registration (the “+” under the “1+” mechanism) will ensure that all the pharmaceutical products approved for registration fulfil the stringent requirements of safety, efficacy and quality. It will also strengthen the local capacity of drug evaluation and enhance the development of relevant software, hardware and expertise.
      
     To progress towards the primary evaluation of drugs and medical devices, “The Chief Executive’s 2023 Policy Address” also announced the set-up of a preparatory office for the establishment of the Hong Kong Centre for Medical Products Regulation (CMPR) to study the potential restructuring and strengthening of the current regulatory and approval regimes for medicines, medical devices and medical technology, and put forward proposals and steps for the establishment of the CMPR. The Government will also explore upgrading the CMPR to be a standalone statutory body in the long run. This will help accelerate the launching of new drugs and medical devices to the market, and foster the development of research and development, and testing of medical products and related industries.
      
     The DH spokesman said that maintaining a drug regulatory system that is on par with the international standard would facilitate the future development of Hong Kong’s local healthcare system and services as well as maintaining international recognition of healthcare technology and clinical research. The DH would adopt a more proactive strategy to review and enhance the arrangement. read more

East Asia