Applicant need to provide an official/ cover letter, application form for Endorsement letter of ancillary component, checklist of the relevant drug category (New Drug Product, Biologic, Generic) and two copies of ancillary drug dossier in the form of electronic copy (CD).

Applicant may apply for classification to NPRA through product classification form to identify the category of ancillary drug component.

The endorsement letter for ancillary drug component shall be valid provided that there are no other changes to the particulars of ancillary drug component.

The endorsement letter for ancillary drug component shall be valid from the issuance date provided that there are no other changes to the particulars of ancillary drug component.

Yes, endorsement letter is required. However, case-to-case basis can be considered if the performance of ancillary medical device is not affected by the drug component.

Yes. Multiple product names with the same specification of ancillary medical device may be allowed in one application.

No. It is advised to list all the drug-medical device products which contain the same ancillary medical device, in one application form for endorsement letter of ancillary component.

It is not required for medical device-drug combination product registration, where the combination is packaged together in a single package, provided that the ancillary drug component is essentially the same as the registered product with a valid registration status with Drug Control Authority.

However, for medical device-drug combination product produced as a single entity, the endorsement letter is required.

Example: An endorsement letter of ancillary paclitaxel is required for registration of coronary drug-coated balloon catheter, although the paclitaxel used has a valid registration status with Drug Control Authority for parenteral use.

Endorsement letter of ancillary medical device component can be uploaded at part Product Validation item 18 of Quest 3+ system during product registration application.

The API/drug substance Manufacturer may submit the Drug Master File (DMF) via electronic copy (CD) directly to NPRA to maintain confidentiality of the contents. The information contained in the closed part of the DMF will be regarded as confidential and will only be evaluated in support of the applications mentioned in the Letter of Access. The confidential information will not be disclosed to any third party without a written authorization from the API/drug substance Manufacturer.