Agencies across the emerging markets have been dealing with lot of ambiguities pertaining to Active Substance. These ambiguities emanate when a number of applicants submit diverse active substance information or Drug Master files (DMFs) on the same active by the same Active supplier (DMF Source). This usually happens when each applicant asks the API supplier to provide DMF on API as per “its own interpretation of requirements” for a specific country. As a result the API supplier ends up sharing a “variety” of DMFs for the same molecule to be submitted to same agency by different applicants. Despite keeping one Route of Synthesis (ROS) such situation would lead into multiple Drug Master Files basis the country of submission. When agency reviews the application for substance part, queries get generated which end up at API supplier’s door.
DDReg team was approached by an active supplier to develop “all-inclusive or Global” DMFs for its set of APIs which has option of extracting standard country/region specific DMF for same API so that same could be shared with the applicant.
In developing an all-inclusive or comprehensive DMF, the biggest challenge was to gather country/region specific API requirement. While strategically, the route of synthesis (ROS) of the active ingredient is kept the same, the Drug Master File authoring has to be based completely upon the country specific regulatory requirements. The challenge here was not to over commit while at the same time meet upto the country specific regulatory requirements for DMF authoring.

The API review team of DDReg was tasked to develop an all inclusive template for DMF. The team studied the active substance requirements for all countries/regions and developed a comprehensive compilation. DMF template was built Section by section. It was extremely important to build up the version control and life cycle management tool for DMF.

Intelligent and smart inputs and tireless effort by the API RA team led to the development of desired template. Based on this template the API specific DMFs were developed.

1. Standard DMF template development with version control and built in option for version control
2. Same set of API data/information submission to agency by multiple API vendors.
3. Leading to minimal queries from Agency on API