Hong Kong – CMAB and HYAB continue to brief association representatives on proposals to improve governance at district level (with photos)

Jun 2, 2023 | International

CMAB and HYAB continue to brief association representatives on proposals to improve governance at district level (with photos)

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     The Secretary for Constitutional and Mainland Affairs, Mr Erick Tsang Kwok-wai, and the Secretary for Home and Youth Affairs, Miss Alice Mak, met with representatives of the Hong Kong Island Federation to explain the proposals on improving governance at the district level today (June 1).

     Mr Tsang and Miss Mak mentioned that the proposals could institutionally prevent ineffectiveness of district administration, ensuring that the District Councils (DCs) will operate in compliance with provisions of the Basic Law to carry out their district service and advisory functions. This enables the Government to co-ordinate departments’ work such that efficacy of district governance will be enhanced and the public will benefit.

     The two Directors of Bureaux said that members of the public supported and expected the five benefits brought by the proposals, namely:

(1) enhance the functions of DCs to allow the Government to have more effective planning and implementation of district services, manifest executive-led governance and better serve the public;

(2) optimise the composition of DCs and the methods of selection of DC members to allow persons with professional knowledge and experience, who are patriotic and have an affection for Hong Kong, to enter the DCs through multiple channels and serve the public;

(3) introduce an eligibility review mechanism to fully implement the principle of “patriots administering Hong Kong” and safeguard national security, and return the DCs to the livelihood-oriented positioning;

(4) introduce a monitoring mechanism of DC members’ performance to ensure that every DC member delivers due diligence and meets public expectations; and

(5) strengthen the district governance structure to formulate and command appropriate measures in response to the demand of the public in an effective and timely manner.

     The District Councils (Amendment) Bill 2023 was introduced into the Legislative Council (LegCo) for the First Reading and the Second Reading yesterday (May 31). The attendees welcomed the progress. The two Directors of Bureaux said that the Government will proactively facilitate the scrutiny of the LegCo and solicit support for the early passage of the Bill from Members of the LegCo, so as to begin the substantial preparation work for the upcoming DC Ordinary Election and so the seventh-term DCs can assume office on January 1 next year as scheduled.

Hong Kong – CMAB and HYAB continue to brief political parties on proposals to improve governance at district level (with photos)

May 9, 2023 | International

CMAB and HYAB continue to brief political parties on proposals to improve governance at district level (with photos)

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     After the Government’s announcement of the proposals on improving governance at the district level on May 2, the Secretary for Constitutional and Mainland Affairs, Mr Erick Tsang Kwok-wai, and the Secretary for Home and Youth Affairs, Miss Alice Mak, immediately commenced explanatory and publicity work for various sectors. The two Directors of Bureaux began to meet different political parties yesterday. They hosted briefing sessions today (May 9) for representatives of the Business and Professionals Alliance for Hong Kong and the Liberal Party respectively to listen to their views and solicit their support.

     At the two briefing sessions today, Mr Tsang and Miss Mak emphasised the necessity and guiding principles of the objectives of the proposals on improving governance at the district level. They also explained details of the proposals, including the filling of the seats through multiple methods, so as to allow persons from different sectors who are patriotic and have an affection for Hong Kong to participate in the work of District Councils (DCs), and thus enhance the efficacy of district governance.

     They pointed out that aside from reforming DCs, there is also a need to strengthen the district governance structure in order to enhance the efficacy of district governance. In this connection, the Government will establish the Steering Committee on District Governance, which will be chaired by the Chief Secretary for Administration, to take a leading role on the overall strategy, policies and measures of district governance; and the Task Force on District Governance to be chaired by the Deputy Chief Secretary for Administration will be repositioned to co-ordinate and direct the district work of various policy bureaux and departments. By establishing a senior leadership and working structure, the leadership and co-ordination of district work will be significantly enhanced.

     The two Directors of Bureaux also said that the Government is going full steam ahead to prepare the District Councils (Amendment) Bill 2023 and hopes to submit it to the Legislative Council (LegCo) for scrutiny as soon as possible. The Government targets to secure the LegCo’s passage of the Bill before the summer recess of the LegCo this year so that the DC Ordinary Election can be held at the end of this year and the seventh-term DCs can take office on January 1 next year as scheduled.

     The attendees shared their views enthusiastically and provided many constructive suggestions. The two Directors of Bureaux also encouraged them to proactively brief various sectors of the community so as to deepen public understanding of the objectives and benefits of the proposals.

     Since the announcement of the proposals on improving governance at the district level, Mr Tsang and Miss Mak attended various radio and television programmes, briefing sessions and media interviews to brief the public, media, Hong Kong deputies to the National People’s Congress, Hong Kong members of the Chinese People’s Political Consultative Conference and different political parties respectively on the proposals. In addition, Government officials also visited street booths in various districts to appeal to the public to support the proposals.

FDA In Brief: FDA Finalizes Guidance with Internationally Harmonized Recommendations to Further Support Safe, High-Quality Human Drug Products

May 11, 2021 | Business

“The FDA is continually working to promote drug innovation and improvement, strengthen quality assurance, safety and supply of drug products and enable more efficient use of industry and regulatory resources. Through the harmonization of requirements for drug lifecycle management, manufacturers and the FDA can meet these goals in less time through effective management of postapproval changes. To help provide a more predictable and efficient approach to management of postapproval changes, today we’re announcing a final guidance for industry with new International Council for Harmonisation (ICH) guidelines.

Effective implementation of this guidance will provide an opportunity for the FDA to focus attention and resources on higher risk postapproval changes, incentivizing manufacturers with additional flexibilities to continually improve their manufacturing processes, which can reduce the likelihood of quality-related supply disruptions and related drug shortages.

This guidance reflects just one element in the FDA’s work with regulatory authorities and industry associations from around the world to promote international harmonization of regulatory requirements under the ICH. The FDA is committed to continue seeking scientifically-based harmonized technical procedures for the development and manufacture of drugs.”

Additional Information

  • Today, the U.S. Food and Drug Administration is announcing the availability of a final guidance for industry, “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” This guidance, which was adopted as an ICH Guideline in November 2019, provides a framework to facilitate the management of postapproval chemistry, manufacturing and controls changes in a more predictable and efficient manner. The guidance discusses how to identify the elements in an application that are considered necessary to assure product quality and therefore would require a regulatory submission if changed postapproval.
  • In addition to postapproval changes, the guidance has the potential to help facilitate innovations in manufacturing through a flexible, risk-based approach to regulatory oversight. Encouraging continual product improvement can help reduce product variability and prevent and mitigate shortages related to manufacturing and quality issues. In addition to benefitting industry and regulators, the approach discussed in the guidance will help to assure that patients have access to high quality therapies.
  • The FDA publishes ICH guidelines as FDA guidances. This guidance is applicable to pharmaceutical drug substances and products (both chemical and biological) that require a marketing authorization and to drug-device and biological product-device combination products that fall under the jurisdiction of the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research. Changes needed to comply with new or revised pharmacopoeial monographs are not within the scope of this guidance.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.