Background
Rationale for providing Template/Guide
Implementation
- The registration process of a generic product requires an application that encompasses Part I (Administrative Data and Product Information) and Part II (Quality) information.
- Section A of Part I involves product particulars that will be translated into the package insert (PI) which is part of Section D.
- According to the ASEAN Glossary used in the ASEAN Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR), a package insert is a document defining information that are supplied with a pharmaceutical product by the marketing authorization holder (MAH).
- Package inserts are required for products classified as Scheduled Poisons and they may also be submitted for Non Poisons (Over the Counter, OTC) products.
- The draft copy of the package insert should be submitted for evaluation as it is a criteria to be fulfilled during the product registration process. The information furnished in the package insert must be identical to the information submitted in Section A of the application form.
- During online applications for generic products, product information submitted by applicants (Section A and package insert) is sometimes inconsistent and there are variations between generic products and also with the innovator product.
- The time for evaluation is affected as evaluators not only have to evaluate the information submitted in both sections but even correct grammatical errors and spelling mistakes.
- For applicants on the other hand, many find it difficult to submit information based on registered products or relevant information as some references are not up-to-date or are not as approved by the Drug Control Authority (DCA).
Rationale for providing Template/Guide
- These templates serve as a guide to applicants on product information based on the information approved for innovator products by the DCA.
- The product information is general and not based on statistics or clinical trials by the innovator product. Therefore the information in these templates are suitable for generic products.
- The product information is arranged according to the requirements for package inserts in accordance to the Drug Registration Guidance Document.
- It will help applicants in submitting/providing product information (Section A and package insert) to ensure consistency in information for all registered generic products.
- It will also help evaluators and ensure consistency during the evaluation process.
- Hence, these templates can bridge the gap for both parties and improve the application and the evaluation process.
- These templates are also furnished with Specific Labeling Requirements for the specific active ingredient (if applicable).
Implementation
- The active ingredients for the templates created have been chosen based on the most common applications submitted to DCA and the number of templates will be increased from time to time.
- The templates are prepared based on information from established references such as Micromedex and Martindale. However the indication is as approved for products registered by DCA
- Updating of the product information/templates will be carried out if/when there are changes made to the innovator product information in terms of indication, dosage regimen as well as any new policy enforced by DCA.
- Applicants are advised to use these templates in preparing information for Section A and package insert that is suitable with the dosage form of their products to be registered.
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