You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

August 1, 2011

Ensuring Smooth Registration of Pharmaceutical Products

Subscribe to Updates
PReMA Life

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.

Download Full Article
Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

September 6, 2024
Addressing technical barriers to trade is a key priority for the Association of Southeast Asian Nations (ASEAN) as part of trade facilitation in achieving the single market and production base under the ASEAN Economic Community directive agreed in 2015. The region has been undertaking positive steps toward standard harmonization in ASEAN priority sectors, integrating and bringing about regulatory convergence by taking into account the diversities that exist in the ten ASEAN member states. Health supplements in ASEAN are under the responsibility of the Traditional Medicine and Health Supplement Product Working Group (TMHS PWG). One of the TMHS PWG’s outputs is the ASEAN Agreement on a Regulatory Framework for Health Supplements, which includes various technical requirements for health supplements that participating member states must adopt by adjusting their domestic regulations. The key ingredients of these health supplements are vitamins and minerals. While all ASEAN countries allow the use of vitamins and minerals in health supplements, the amounts allowed for use vary, depending on the nutritional requirements deemed appropriate by each country. Partly in response to these efforts for regional harmonization, there have been important changes to vitamin and mineral limits in certain ASEAN countries that are worth monitoring. Some of these are outlined below. Thailand In January 2024, the Thai Food and Drug Administration (TFDA) updated the Thai Recommended Daily Intake (Thai RDI) guidelines for the Thai population. Subsequently, the TFDA adjusted the vitamin and mineral limits in order to comply with the updated Thai RDI and to follow the ASEAN Agreement on a Regulatory Framework for Health Supplements. The TFDA’s adjustment of vitamin and mineral limits for use in food supplements came in Notification of the Ministry of Public Health (No. 448) B.E. 2566 (2023) Re: Food Supplements (No. 5), which was published in the Government Gazette on January
Read More
August 8, 2024
On July 19, 2024, Thailand’s Ministry of Public Health Notification No. 450 B.E.2567 (2024) came into effect after being published in the Government Gazette the day before. The notification introduces significant updates to the labeling requirements for prepackaged foods. This new regulation consolidates and updates Thailand’s rules for food labeling by repealing and replacing several previous notifications. The notification’s key changes and their implications for food businesses are identified below. 1. Clarified “Best Before” Definition The notification aligns the definition of “best before” with Codex standards. It now refers to the date marking the end of the period during which the food maintains its best quality under stated storage conditions. After this date, food quality may change, and the product cannot be marketed. 2. Updated Labeling Exceptions Certain foods are exempt from labeling requirements, with the latest list including: Foods sold directly to consumers by manufacturers who can provide product information. Unprocessed foods. Some fresh foods not sold directly to consumers. Prepackaged foods produced and sold for immediate consumption in food service settings. However, any of these exempt foods that have received food serial numbers must still have labels that comply with the notification. 3. Expiration Date and Best-Before Date Display The notification provides clearer language for displaying the expiration date and best-before date. If specific wording is required by other notifications, it must be followed. English equivalents are now permitted alongside Thai text. 4. Warning Displays Multiple applicable warnings can now be consolidated and displayed together, provided the complete message is included as specified. 5. Claims about Substances or Ingredients New guidelines have been established for making claims about food additives and ingredients. Claims should be factual, not deceptive, and provably not false. 6. Label Placement and Design Labels must be permanently affixed, proportionate to the packaging, and
Read More
August 8, 2024
Tilleke & Gibbins has contributed the Thailand chapter to the 2024 edition of Pharmaceutical Advertising from the International Comparative Legal Guides (ICLG) series published by Global Legal Group. This detailed guide offers an in-depth examination of pharmaceutical advertising laws and regulations in multiple jurisdictions around the globe. Each chapter of the guide, structured in a Q&A format, is organized into comprehensive sections covering various aspects of pharmaceutical advertising, including: General rules and codes of practice governing pharmaceutical advertising Required arrangements for ensuring compliance with advertising regulations Procedures for obtaining advertising approvals from regulatory authorities Penalties for non-compliance with advertising rules Guidelines for providing information prior to product authorization Requirements for advertisements directed at healthcare professionals Restrictions on the content of pharmaceutical advertisements The complete Thailand chapter is available as a PDF below. The Thailand chapter—and the full Pharmaceutical Advertising guide—are also freely available on the ICLG website.
Read More
July 31, 2024
On July 18. 2024, Vietnam’s Ministry of Health issued Circular No. 12/2024/TT-BYT promulgating National Technical Regulation QCVN 20-1:2024/BYT on the limits of contaminants for health supplements (“Circular 12”). The new national technical regulation is the very first relating to health supplements, and is expected to have a great impact on the control of health supplement quality in Vietnam. Circular 12 will take effect on August 1, 2025. Contents of Circular 12 The new circular prescribes limits of contaminants (heavy metals and microorganisms), testing samples and testing methods, management requirements, and responsibilities of entities manufacturing and trading in health supplements. Supplemented alcohol products which are declared as health supplements are notably excluded from the scope of the regulation. Transitional Provisions Health supplements which (i) have been granted a declaration registration certificate, and (ii) are manufactured before August 1, 2025, are allowed to continue to be imported, traded, and circulated until the expiry date of the product, even if it is not aligned with Circular 12, except when there is food safety warning. Declaration registration dossiers for health supplements submitted before August 1, 2025, will continue to be handled in accordance with the prevailing regulations at the time of submission. From August 1, 2025, if a health supplement with a granted declaration registration certificate has a manufacturer’s standard that does not comply with Circular 12, the party manufacturing/trading in the product must adjust the product standard to conform to Circular 12 and notify the authority of this adjustment.
Read More