19/12/2024

On November 22, 2024, the Philippine Food and Drug Administration (FDA) issued the new Administrative Order No. 2024-0015 to update rules, requirements and procedures related to Licences to Operate (LTO) for pharmaceutical and medical device companies.

This Order replaces the previous one of 2020, introducing more harmonised guidelines and specific requirements for all companies involved in the production, import, export, sale and management of sanitary products. The order covers all Medical Devices, including those that emit radiation, in vitro diagnostic Medical Devices, custom-made Medical Devices and reprocessed devices. Companies must comply with technical conformity assessment requirements, including factory inspection by the Philippine FDA, to ensure the safety and quality of healthcare products placed on the market.

The objectives of the new order include:

  • Prescribe updated rules, requirements and procedures for the initial application, renewal and variation of Operating Licences (LTOs) through the FDA eServices Portal system.
  • Aligning with accepted international standards and new local regulations, improving structures, processes and mechanisms for LTO requests.
  • Extend longer validity periods for operating licences and establish administrative review mechanisms in regulatory processes.

The new LTO validity periods are extended: for medium-sized companies, the duration is up to six years for initial and renewed licences, while for large companies it is up to 12 years. In contrast, micro and small enterprises get 3 years for initial LTOs and 6 years for renewals.

The regulation will come into force from the date of its official publication.

Here is a look at the timing of the application:

  • Existing and pending applications for an Operating Licence (LTO) received before the entry into force will be processed according to the provisions of the previous DOH AO No. 2020-0017 until the applications are exhausted.
  • New major and minor variation applications will be subject to the updated guidelines set out in the new regulation as of their entry into force.
  • Preliminary inspection for the licence is maintained for manufacturers of Medical Devices and will be required for other pharmaceutical establishments within five years of the entry into force of the Order. The FDA will notify the specifications of the preliminary inspection if the period is less than five years.
  • The changes for the list of sources/suppliers/customers will be effective immediately for pharmaceutical manufacturers upon entry into force, while a one-year transitional period will apply for other healthcare products.
  • A pilot phase involving interested parties will last for a maximum of six months from the entry into force of the Order.

These measures were established to harmonise local regulations with international standards, optimise regulatory processes and improve the safety and efficacy of healthcare products.
For further details, see the complete Administrative Order.

SOURCE:
https://www.fda.gov.ph/category/administrative-order/

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