FAQ drug-medical device combination product endorsement letter
- General
- Endorsement Letter
- Renewal (Re-Registration) Of Product Registration
- Variation On Ancillary Component
- Variation on Medical Device-Drug Combination Products
ENDORSEMENT LETTER
1. How to apply for endorsement letter?
2. What are the documents required prior to submission?
Applicant need to provide an official/ cover letter, application form for Endorsement letter of ancillary component, checklist of the relevant drug category (Non-Biologic, Biologic) 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.
3. Where shall the applicant submit the required documents?
Applicant shall submit the required documents manually to :
Product & Cosmetic Regulatory Coordination Section,
Centre of Regulatory Coordination & Strategic Planning,
National Pharmaceutical Regulatory Agency,
36, Jalan Profesor Diraja Ungku Aziz, Pjs 13,
46200 Petaling Jaya, Selangor.
4. What will the applicant receive after the submission of the endorsement letter?
Applicant will receive an acknowledgement receipt upon satisfactory screening of the dossier within thirty (30) working days.
5. What is the validity of the endorsement letter for 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.
6. Will the endorsement letter still be valid at the point of registration approval if there is time gap between the issuance of endorsement letter and the actual approval date of product registration?
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.
7. Is an endorsement letter of ancillary medical device component still required for registration of drug-medical device combination product if the medical device is already registered with Medical Device Authority?
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.
8. Will the name of the combination product be stated in the endorsement letter issued by the Medical Device Authority?
Yes. Multiple product names with the same specification of ancillary medical device may be allowed in one application.
9. Can the endorsement letter of ancillary medical device be used for registration of multiple combination products?
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.
10. Is the endorsement letter of ancillary drug component still required for registration of medical device-drug combination product, if the drug component used is a registered product with Drug Control Authority?
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.
11. Is GMP (Good Manufacturing Practices) compliance evidence for manufacturer of active pharmaceutical ingredient (API)/drug substance required for application of endorsement letter of ancillary drug component?
Yes
12. Where should I attach endorsement letter of ancillary medical device component, during registration of drug-medical device combination product?
Endorsement letter of ancillary medical device component can be uploaded at part Product Validation item 18 of Quest 3+ system during product registration application.
13. Can API/drug substance manufacturer submit confidential documents for ancillary drug?
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.