6 Key Challenges in South Korea’s Pharma Regulations & Solutions
South Korea is a rapidly growing pharmaceutical market with a well-established regulatory framework governed by the Ministry of Food and Drug Safety (MFDS). However, foreign pharmaceutical companies often face complex MFDS regulations when entering the market. Understanding these challenges and developing a strong regulatory submission strategy is essential for successful market entry. Here are six key regulatory challenges and strategies to overcome them: 1. Registration of Overseas Manufacturing Facilities Foreign manufacturers must register their facilities with the MFDS before import declaration. This process involves strict compliance with MFDS regulations, detailed documentation, and adherence to Good Manufacturing Practices (GMP). How to Overcome It: Ensure early registration through the MFDS online platform. Maintain comprehensive documentation to meet MFDS regulatory submission requirements. Collaborate with local regulatory experts to streamline the submission pro...
Comments
Post a Comment