Access Regulatory Partners Launches DMFGateway™ Drug Master File Registration Service in China for API Manufacturers
Following SFDA's Mandate, Access Regulatory Partners provide Drug Master File Submission using its offices in China.
- Bridgeport, CT (1888PressRelease) August 15, 2019 - Access Regulatory Partners (ARP) announced today its new services DMFGateway™ to register Drug Master File in China for API Manufacturers worldwide. The new offering is part of ARP’s initiatives to help pharmaceutical, chemical and other industries to expand or strengthen their base in China.
“Since SFDA had stopped accepting registration applications independently for Active Pharmaceutical Ingredients, Pharmaceutical Excipients and Pharmaceutical Packaging Materials and now accept only as part of the drug product application. This requires API, Excipient and Packaging material manufacturers to register their product Drug Master File (DMF) with SFDA. Our new service line is right in time to help our partners continue their business in China”, said Andy Thomas, Director of ARP.
“China’s Drug regulations are often complex, including the challenges due to language barriers. SFDA has been making strides in opening the market to global players by streamlining and harmonizing regulations to global standards. This is one such step towards globalization and we are right here in the action to fill the gap”, added Andy.
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