Martin Christopher T. Belmonte
The Department of Health (“DOH”) issued on 20 September 2024 Administrative Order No. 2024-0013 (“Order”), which provides guidelines for the registration of pharmaceutical products and active pharmaceutical ingredients (“APIs”) intended for human use. The Order seeks to streamline covered registration processes and establish the general guidelines for different authorizations, application types, and registration pathways. Among other issuances, the said Order explicitly repealed A.O. No. 96 series of 1990 [Guidelines on the Registration of Fixed-Dose Combination Drug Products], A.O. No. 17 series of 1992 [Providing for the Classification of Household Remedies], and A.O. No. 23-c series of 2000 [Policies and Guidelines on Over-the-Counter (OTC) Drug Products]. The Order took effect on 11 December 2024.
Product Categories
Pursuant to the provisions of the Order, pharmaceutical products and APIs are categorized into several classes: (1) Chemical drug; (2) Biological drug; (3) Radiopharmaceutical; (4) Homeopathic drug; (5) Medical gas; (6) Herbal medicine; (7) Traditional Medicine; and (8) Orphan drug. Said list is not exclusive and the Philippine Food and Drug Administration (“FDA”) is not precluded to include other types of pharmaceutical products and APIs as it may deem necessary. Moreover, said pharmaceutical products are further classified based on their safety and accessibility to the market, distinguishing between prescription and non-prescription products. Non-prescription products are also sub-categorized as either pharmacist-only or those for general sales. In accordance with these classifications, the FDA is also mandated by the Order to publish an updated list of the APIs with their corresponding pharmaceutical product classifications.
Types of Applications
The Order likewise classifies the different types of applications for authorizing the sale and use of Pharmaceutical products and APIs in the Philippines. Under Marketing Authorization applications, there are: (1) New Pharmaceutical Product Applications (NPPA) and New Biological Pharmaceutical Product Applications (NBPPA); (2) Biosimilar Product Applications; (3) Generic Pharmaceutical Product Applications (GPPA); (4) Identical Pharmaceutical Product Applications (IPPA); and (5) Active Pharmaceutical Ingredient Applications (API). Next are those for DOH-Use-Only Authorization, intended for pharmaceutical products with no valid marketing authorization, and designated for DOH use only. Lastly, are Foreign Donation Authorizations, which must adhere to the World Health Organization (WHO) Guidelines on Medicine Donations.
General Conditions
The eligibility requirements for the registration of applications for the Market Authorization of locally manufactured, imported, and identical pharmaceutical products and APIs are also listed in the Order. Such requirements include, among others, the possession of a valid License to Operate as a drug manufacturer, trader, distributor, or importer, as well as a Certificate of Good Manufacturing Practice compliance issued by the FDA.
It also enumerates the eligibility requirements for DOH-use-only authorization, whereby only applications submitted by the DOH may be authorized. As for pharmaceutical products donated by foreign entities, only applications endorsed by the DOH for use during non-emergency situations are eligible. Said donations must also be from entities engaged in the importation, facilitation, and management of all regular donations of foreign origin covering pharmaceutical products.
Moreover, the aforementioned authorizations for pharmaceutical products and APIs require approval from the FDA to enable their use as finished products or their marketing as raw materials in the Philippines, respectively. The FDA shall likewise require a declaration under oath by the applicant verifying the above-mentioned information.
FDA Assessment, Evaluation, and Decision
Prior to a formal review, all registration applications undergo pre-assessment by the FDA to ensure compliance with the said requirements. The FDA shall then evaluate the suitability of the application considering its benefits and risks in the Philippine context. To achieve this, the FDA utilizes both internal resources and external consultants specializing in pharmaceutical and public health sciences. If the application conforms to the FDA standards for authorization, the applicant shall be issued a Certificate of Product Registration (“CPR”) reflecting the type of authorization granted. However, the application shall be disapproved if the applicant does not meet the required standards, misrepresents required information, violates any conditions, or due to other analogous causes.
Post-Authorization Applications
The Authorization Holder is responsible for notifying the FDA of any changes to their pharmaceutical products or APIs that could impact their safety or quality throughout the validity of their CPR. Such modifications must be reported to the FDA through a Post-Approval Change (PAC) application. Authorization Holders who apply for renewal before the expiration of their CPRs are also eligible for automatic renewal. Moreover, Marketing Authorization and DOH-Use-Only Authorization Holders with lapsed CPRs may apply for such renewal within one hundred twenty (120) calendar days from its expiration. These applications shall be considered valid and existing until a decision by the FDA thereon. Beyond such period, the pharmaceutical products or APIs shall be considered not eligible for renewal. Authorization Holders may also file a formal notification for the cancelation of their CPR voluntarily at any time during its validity.
Validity of Certificate of Product Registration
The CPR issued by the FDA for Marketing Authorization and DOH-Use-Only Authorization shall be valid for six (6) years. Thereafter, such CPRs may be renewed for another six (6) or twelve (12) years, at the discretion of the applicant. CPRs for Foreign Donation Authorization shall only be valid for one (1) year.
Reconsideration and Reapplication
Applicants whose applications for authorization are disapproved by the FDA may submit a one-time request for reconsideration or reapplication. An administrative reconsideration may be filed with the Office of the Director General of the FDA through a formal request within fifteen (15) calendar days after their receipt of the Letter of Disapproval (“LOD”). The FDA shall resolve such a request within sixty (60) working days. A reapplication on the other hand may be applied for by submitting a request with the deficiencies listed in the LOD and any necessary supporting documents within forty (40) calendar days upon receipt of the LOD.
Suspension or Revocation
Any authorization issued pursuant to this Order may be automatically suspended or revoked by the FDA without notice and hearing in instances of willful violation of FDA-Implemented laws, or when public health or safety requires such. The Authorization Holder shall then have forty-eight (48) hours to show cause why such suspension or revocation should not remain in force. The authorization shall also be suspended or revoked after notice and hearing if the Authorization Holder is found to have not met the required standards, misrepresented any relevant information, violated the terms and conditions of their authorization, or for any other analogous causes.
Administrative Order No. 2024-0013
For further details or to view the complete text and annexes of Administrative Order No. 2024-0013, please refer to the official link: https://www.fda.gov.ph/wp-content/uploads/2024/09/Administrative-Order-No.-2024-0013.pdf