On June 28, the NMPA said it plans to improve services to foreign medical companies. Primarily, this message is to further help foreign drug and medical device companies with more efficient product registration. Their focus will be primarily on the pediatric and rare disease... Read More
On June 16, the Filipino FDA issued circular 2022-0045 named “Establishing Facilitated Registration Pathway for Drug Products”. This circular discussed how Reference Drug Regulatory Agencies (RDRA) can expedite drug, vaccine, and biologic approvals in the Philippines. If an RDRA has approved a... Read More
RWE or real-world data are now becoming more important for drug and medical device approvals and reimbursement in China. Since 2019, when Hainan Island released regulations emphasizing the value of RWE, similar RWE regulations have also been issued by the NMPA for... Read More
Due to manufacturing problems with some generic products, the MHLW will now bolster GMP via issuing a new inspection manual. This inspection manual will apply to both generic and new drugs. Representatives from various pharmaceutical associations, the PMDA, and others have now set up... 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
The Filipino FDA has proposed a shorter review time for drugs if their clinical studies are completed successfully and approved by the US FDA, PMDA, TGA, EMA, and UK/Canadian FDAs. These approvals would only apply for drugs that can help with health... Read More
As drug registration applications grow dramatically in China, so will the CDE audits of drug manufacturing facilities according to the Center for Drug Evaluation (CDE). Earlier this year, the CDE set up a 3-tier system for audits of drug factories including low,... Read More
China’s law (Implementing Regulations of the Drug Administrative Law) is currently being updated and out for public comments until June 9. The draft regulation includes over 181 articles or over 100 more articles than the current law. Some possible changes among other... Read More
On May 9, the MHLW issued a notice that they will accept online applications for drugs, medical devices, and regenerative medicine products. Other types of products that can be submitted online include applications for API master files, GCP/GPSP onsite inspections, and partial... Read More
Opportunities in China for novel drugs will continue to grow despite recent NRDL price cuts. For example, Novartis sales in China are close to $3.1 billion a year, and last year sales grew by double digits. 2025 sales are expected to top $4.2 billion... Read More