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Drug Master File (DMF) Systems in Asia

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

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Thai IVD and Medical Device Updates

In January, the Thai Food and Drug Administration (Thai FDA) released updated Change Notification Guidelines for In Vitro Diagnostic (IVD) products. The new guidelines took effect on January 15, 2025. To add medical device items, manufacturers must submit change requests that must be... Read More

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2024 Thailand Pharmaceutical Regulatory Update

In recent years, Thailand, a Southeast Asian country with 70 million people, has been consistent in its commitment to improving the regulation of pharmaceuticals, ensuring the safety, efficacy, and accessibility of drugs in the market. Two significant developments include the initiation of... Read More