On July 31, 2024, the Taiwan Food and Drug Administration (TFDA) officially launched digital GMP certificates. These certificates comply with international PIC/S GMP standards and feature advanced encryption via a digital signature recognized by Taiwan’s Electronic Signatures Act and the global Adobe... Read More
In late 2024, the National Medical Products Administration of China (NMPA) and six other government agencies published the Draft Administrative Measures for Management of Medical Representatives (Draft Management Measures) to update the 2020 Record-Filing Measures. The goal of this publication is to further... Read More
On November 14, China’s NMPA announced the document titled “Interim Provisions on the Administration of the Designation of Domestic Responsible Persons by Overseas Drug Marketing Authorization Holders.” These provisions outline the requirements for domestic responsible persons. Imported pharmaceuticals’ quality and safety are... Read More
On October 21, 2024, China’s NMPA rolled out a pilot plan that allows non-end-to-end and segmented production of biologics between different facilities. In the past, the NMPA insisted the entire production process be done inside a single facility. This pilot plan is... Read More
The National Medical Products Administration (NMPA) in China has released a draft Medical Device Administrative Law (MDAL) and is soliciting comments from stakeholders. The MDAL is a novel promulgation in China. A notable proposed change is the elimination of the existing country... Read More
The Hong Kong government has been updating its regulatory framework for medical devices, with a number of key changes that seek to enhance safety, efficacy, and compliance. Compulsory Procurement Registration On June 21, 2023, the Hong Kong Department of Health (DOH) launched... Read More
Market Authorizations (MAs) for drugs in Thailand before 2019 never expired. With the implementation of the 2019 Thai Drug Act, drug MAs were only good for 7 years but could be renewed. Now, the Thai Drug Act has set out a detailed... Read More
On April 11, the NMPA issued a new Circular on year-end drug annual reporting. China MAH’s must submit 2021 annual reports by August 2022. However, after this year, annual reports must be submitted by the end of April each year. The circular... Read More
Spotify: https://open.spotify.com/episode/61krNTBfW9nKHadjtOOIuT?si=zGlmcBWnTUKGYT7qXOo1XQ&dl_branch=1 Apple: https://podcasts.apple.com/us/podcast/project-medtech/id1513851432?i=1000527075358 Read More
Being a local agent for medical devices in China is going to get significantly more rigorous. Some of the new requirements now in draft form will be implemented soon. According to the new regulations, the NMPA organized the drafting of “Measures for... Read More