In the international pharmaceuticals industry, Good Manufacturing Practice (GMP) compliance is a fundamental foundation for the safety, quality, and efficacy of drugs. With expanding supply chains and more complex global partnerships, knowledge of the quality compliance environments of leading Asian pharmaceutical markets... Read More
Introduction Quality, safety, and efficacy are of the utmost importance for drug products. A vital part in achieving this is having a Drug Master File (DMF). A DMF is a confidential submission to a health authority to provide detailed information about the... Read More
The Korean Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) are seeking new ways to counteract long registration and market access timelines for healthcare products. Both agencies have been vigorously implementing new ways to get... Read More
In the Asia-Pacific (APAC) region, regulators are taking important steps to shape the future of artificial intelligence (AI) in medical technology. With that progress comes recognition of the usefulness and transformative potential of AI, and the necessity for new levels of oversight.... Read More
In early March, the Korean Ministry of Food and Drug Safety (MFDS) announced proposed amendments to the Standards for Medical Device Manufacturing and Quality Management. These amendments aim to speed up the process of granting compliance certification for medical devices. Under this... Read More
Korea’s Ministry of Health and Welfare announced today that a sweeping reform will change pharmaceutical pricing from March onwards. The reform will be called the “Measures to Improve Drug Pricing Systems to Reward Innovation and Strengthen Health Security”. The goal of the reforms will... Read More
The Korean Ministry of Food and Drug Safety (MFDS) plans to continue strengthening its support for innovative medical products, including new drugs, advanced biopharmaceuticals, and medical devices. The effort is meant to expedite the development and market release of innovative healthcare solutions. At a... Read More
On February 21, 2025, Korea introduced the Regenerative Medicine Law, which will enable patients suffering from serious, rare, or untreatable diseases to gain access to cell and gene therapies that are not yet fully approved for marketing. The law’s full title is ... Read More
On January 24, the Korean MFDS made public that it would put together and publish the world’s first Guideline for Approval and Review of Medical Devices Using Generative Artificial Intelligence (AI). To this end, the MFDS has formed a special group of... Read More
As mentioned in our earlier newsletter, Korea has implemented a new drug approval system to expedite drug approvals, which began on January 1, 2025. To do so, the MFDS has increased its fees by 50x to hire more staff, etc. However, the industry has complained... Read More