Remember to monitor deadlines in CTIS during the summer period​Danish Medicines Agency

 As the summer season approaches, we would like to draw your attention to the need for forward planning in connection with the holiday period. All case processing will continue as usual in CTIS.

However, please note that Denmark’s initiative for expedited processing of Phase I and integrated Phase I/II trials will not be available during weeks 29–31, 2026. Please read more here.

2nd Interface Meeting between the ASEAN Intergovernmental Commission on Human Rights (AICHR) and Norway​ASEAN Main Portal

  The 2nd Interface Meeting of the ASEAN Intergovernmental Commission on Human Rights (AICHR) and Norway was held on 20 May 2026 at the ASEAN Headquarters/ASEAN Secretariat. The Meeting was chaired by the Acting Chair and Alternate Representative of the Philippines to AICHR, Bolivar L. … Continue reading 2nd Interface Meeting between the ASEAN Intergovernmental Commission on Human Rights (AICHR) and Norway​ASEAN Main Portal

Secretary-General of ASEAN Delivers Remarks at the Groundbreaking Ceremony for the construction of Timor-Leste’s International Convention Centre in Dili​ASEAN Main Portal

  Secretary-General of ASEAN, Dr. Kao Kim Hourn, today delivered remarks at the Groundbreaking Ceremony for the construction of Timor-Leste’s International Convention Centre (ICC), in Dili. The Ceremony was officiated by H.E. Kay Rala Xanana Gusmão, Prime Minister of the Democratic Republic of Timor-Leste. SG … Continue reading Secretary-General of ASEAN Delivers Remarks at the Groundbreaking Ceremony for the construction of Timor-Leste’s International Convention Centre in Dili​ASEAN Main Portal

Secretary-General of ASEAN Attends the Commemoration of the 24th Anniversary of the Restoration of Independence of the Democratic Republic of Timor-Leste​ASEAN Main Portal

  Secretary-General of ASEAN, Dr. Kao Kim Hourn, today attended the commemoration of the 24th Anniversary of the Restoration of Independence of the Democratic Republic of Timor-Leste, in Dili. The occasion reflected Timor-Leste’s remarkable journey of peace, stability, prosperity, resilience, nation-building, and progress, as well … Continue reading Secretary-General of ASEAN Attends the Commemoration of the 24th Anniversary of the Restoration of Independence of the Democratic Republic of Timor-Leste​ASEAN Main Portal

5th Interface Meeting between the ASEAN Intergovernmental Commission on Human Rights (AICHR) and the Mission of Japan to ASEAN​ASEAN Main Portal

  The 5th Interface Meeting of the ASEAN Intergovernmental Commission on Human Rights (AICHR) and the Mission of Japan to ASEAN was held on 20 May 2026 at the ASEAN Headquarters/ASEAN Secretariat. The Meeting was chaired by the Acting AICHR Chair and Alternate Representative of … Continue reading 5th Interface Meeting between the ASEAN Intergovernmental Commission on Human Rights (AICHR) and the Mission of Japan to ASEAN​ASEAN Main Portal

Secretary-General of ASEAN to participate in the 32nd Asia-Pacific Economic Cooperation Ministers Responsible for Trade Meeting in Suzhou, China​ASEAN Main Portal

 

At the invitation of H.E. Wang Wen Tao, Minister of Commerce of the People’s Republic of China and Chair of the Asia-Pacific Economic Cooperation (APEC) Ministers Responsible for Trade (MRT) Meeting for 2026, Secretary-General of ASEAN, Dr. Kao Kim Hourn, will participate in the 32nd APEC MRT Meeting in Suzhou, China, on 22–23 May 2026. During the Meeting, Dr. Kao is scheduled to deliver interventions at the MRT Plenary, participate in the Dialogue between the Regional Comprehensive Economic Partnership (RCEP) and the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) Ministers, and the Luncheon between APEC Ministers Responsible for Trade and the Business Community. Dr. Kao is also scheduled to hold a series of bilateral meetings with Ministers and representatives from external partners countries of ASEAN, on the sidelines of the meetings. Subsequently, Dr. Kao will also deliver Opening Remarks at the Inauguration Ceremony of the ASEAN-China Artificial Intelligence Industry Innovation Centre in Beijing, China, underscoring the event’s importance in advancing ASEAN–China cooperation in the digital era.

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WADA signs three-year memorandum of understanding with ASEAN​ASEAN Main Portal

 

JAKARTA and MONTRÉAL, 19 May 2026 -Today, the World Anti-Doping Agency (WADA) announced that it has signed a Memorandum of Understanding (MoU) with the Association of Southeast Asian Nations (ASEAN) to collaborate on a range of anti-doping programmes development activities.

Formed in 1967, ASEAN is an intergovernmental organisation established by the ASEAN Charter that is committed to intensifying community building through enhanced cooperation and integration by its 11 Member States.

Building on the MoU formalised in March 2022, the new agreement was signed by WADA President Witold Bańka and Secretary-General of ASEAN Dr. Kao Kim Hourn, and will run for an initial term of three years with the objective of bolstering the efforts of ASEAN’s Member States in the protection of clean sport in Southeast Asia.

As part of the MoU, ASEAN, in collaboration with WADA, will support its Member States in implementing the updated World Anti-Doping Code (Code) and International Standards; harmonising national anti-doping policies and legislation; and supporting the operational independence of National Anti-Doping Organisations (NADOs) in the region.

WADA President, Witold Bańka, said: “WADA is pleased to continue its productive collaboration with the Association of Southeast Asian Nations. The original MoU set the foundation for ASEAN to support the development of robust and compliant Anti-Doping Organisations in the region, and for Member States to take tangible steps forward in strengthening and harmonising their anti-doping programmes.

“ASEAN will have a key role to play in the region with regards to the implementation of the 2027 World Anti-Doping Code and International Standards, and WADA, in cooperation with the Southeast Asia Regional Anti-Doping Organisation (SEARADO), will support in this important endeavor. We look forward to continuing to work with ASEAN in the years to come to continue to build up anti-doping capacity in Southeast Asia, to ensure that athletes can be confident they are competing on a level playing field.”

Dr. Kao Kim Hourn said: “The ASEAN is ready to further its commitment to the protection of clean sport as a key regional priority and the continued development of its Member States’ anti-doping programmes. Through our cooperation with WADA, we have taken strides in the region, and we are optimistic that over the next three years, our continued cooperation will reinforce a coherent regional sports integrity framework through anti-doping compliance and ethical governance.”

The MoU also indicates plan for ASEAN to conducting education activities in the region; supporting and promoting the work of WADA’s Asia/Oceania Office; and engaging regional public authorities and sporting federations in the development of strong anti-doping policies and programmes.

Meanwhile, WADA will continue to support regional ASEAN initiatives and implement common projects for its Members, while assisting with the technical implementation of Code requirements and anti-doping practitioners’ development. ASEAN will continue to be invited to regional and international WADA events, including the upcoming Asia/Oceania Region Intergovernmental Ministerial Meeting on Anti-Doping in Sport and Regional Symposium for Asia/Oceania, which will take place in Beijing, China, between 1-3 June 2026.

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NMPA Clinical Updates: What Overseas Manufacturers Need to Know About the 5 New Class III Devices Guidelines​China Med Device

 

NMPA published 5 medical devices final guidelines on April 30, 2026. They are aimed to facilitate manufacturers with clarity in clinical evaluation requirements. All five guidance documents are directed at Class III devices, which is the fundamental reason why the NMPA imposes strict requirements on clinical trials or same-type clinical evaluations. Why Overseas Manufacturers Should […]

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11 Class III Devices and 66 IVDs to be Newly Exempted from Clinical Trial; Feedback until May 29​China Med Device

 

NMPA published the “Clinical Evaluation Exempt Draft Catalog for Medical Devices” and “Clinical Evaluation Exempt Draft Catalog for In Vitro Diagnostics” on April 30, 2026. Feedbacks need to be submitted by May 29, 2026. It proposes to newly-include 11 Class III medical devices and 66 Class III IVDs into the exemption list. Implementing risk-based clinical […]

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ACLA Statement on Introduction of the Enhancing Clinical Laboratory Innovation and Access Act (Enhancing CLIA Act) of 2026​American Clinical Laboratory Association

 

Washington, D.C. – In response to the introduction of the Enhancing Clinical Laboratory Innovation and Access Act (Enhancing CLIA Act) of 2026, the following statement can … Read More

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