Generic Drug Registration in the Philippines

Generic Drug Registration in the Philippines

The Philippines is the third-largest pharmaceutical market in ASEAN after Thailand and Indonesia. In 2019, total generic drug sales were in the Philippines were PHP82.3 billion, and accounts for 63% of prescription sales and estimate to reach PHP110 Billion by 2024. The highest cost of medicines in the Philippines among other ASEAN countries is one driving factor for more generic drugs purchase than branded medicines. Foreign pharmaceutical companies account for over 75% of the Philippines’ pharmaceutical market.

Top key factors for the generic drug market growth in the Philippines

  • Fast-growing population.
  • Progressive government investment in the health care sector, and growing per capita expenditure on pharmaceuticals.
  • Increasing pharmaceutical imports and expected to reach $1.4 bn in the future.
  • Increasing sales of generic drugs. Around 60% of pharmaceutical sales are of generic drugs while 40% of branded medicines.
  • Supportive government initiative to increase access and demand for affordable and quality medicines. Example Universal Health Care Policy, BnB project (Botika ng Barangays), Cheaper Medicine Act 2007, etc.

To register your generic drug in the Philippines you need to know the following

  • What are various application categories for generic drug registration in the Philippines?
  • How can foreign manufacturers register their generic drugs in the Philippines?
  • How about BA/BE studies?
  • Is the foreign bioequivalence data acceptable in the Philippines?
  • What are the requirements to register your generic drug in the Philippines?
  • How about the manufacturing site accreditation, or other such requirements for drug registration?
  • What are the timelines and costs involved in generic drug registration?
  • What is the post-approval process such as importation and license to import?

Get Details on Regulatory, Requirements, and Process for Registering Generic  Drugs in the Philippines.

Credevo has prepared this report by collecting the relevant information as per the current understanding and awareness of Credevo. Click on the blue button below to download the report.

Note: The details presented in the report are intended to help in creating awareness about the regulatory process and requirements for registering generic drugs in the Philippines. While the report can be considered as an informative resource, it is not being presented as legal guidance, a binding document, or any authoritative report. The information in this report was prepared based on relevant information from the public domain as of the date, however, the regulations and requirements may change with time and it is advisable to refer to current regulations at any given time. It is recommended to confirm the specific details, requirements, and processes applicable to your specific products at a given time before initiating any process of registration.