The registration of a pharmaceutical product with the Food and Drug Administration (FDA) can be extremely time consuming, even for straightforward cases. In order to avoid any delays, it is important that the product dossier be meticulously prepared prior to submitting all relevant documents to the FDA, especially the quality part of the documentation.

We discussed the issue with the Department of Medical Science (DMSc) quality part examiners to clarify the process, provide key pointers to avoid common mistakes, and obtain their views and opinions on some of the most common difficulties typically encountered when reviewing a dossier.

Regulatory Changes

Due to changes in requirements from ASEAN Harmonization of Standards and Technical Requirements for Pharmaceutical Products, applicants should carefully follow the developments of the regulations for product registration to ensure that there are no missing documents and that they have not overlooked any newly introduced requirements.

Method Verification and Method Validation

New applications will likely have to be filed for all non‐ASEAN compliant pharmaceutical products, or amendments will have to be made to the quality part of such products. This includes the Method Verification and Analytical Method Validation aspects.

The Method Verification is the confirmation procedure by performing the analytical method in complying with the compendia method for the users of such methods. The manufacturers who use the United States Pharmacopoeia analytical method have to demonstrate their competence in successfully operating the method by providing the documents to verify the suitability of such methods.

The Analytical Method Validation is a confirmatory process of performing several tests which are designed to verify that an analytical test system is suitable for its intended purpose, and is capable of providing useful and valid analytical data. Thus, Analytical Method Validation is required for a newly developed method, non compendia, such as an in‐house method (i.e., a method that was developed by the manufacturer itself), and modified compendia procedures etc.

Applicants should also ensure that references from pharmacopoeia are not obsolete when submitting documents for the analytical part of the assay.

Zone IVb Stability Data

All previously registered pharmaceutical products have until 2012 to amend the stability data provided in their respective dossiers. Zone IVb stability data of 30 C +-2, 75 +-5% RH is now required. This includes long term and real time Zone IVb Stability data, which is a new requirement

Carefully prepared data that meets the FDA guidelines will hopefully avoid any unnecessary delays and ensure the earliest and smoothest product launch.