Administrative Order 2024-0013 establishes updated rules for the registration of pharmaceutical products and Active Pharmaceutical Ingredients (APIs) for human use, aligning with regional and global regulatory harmonization efforts. The Order aims to streamline registration processes and provide clear guidelines for various authorizations, application types, and registration pathways.
Key Changes:
1.Types of Applications
a. Marketing Authorization Applications (MAA):
i. New Pharmaceutical Product Application (NPPA) and New Biological Pharmaceutical Product Application (NBPPA):
1. NPPA/NBPPA-1: First strength of a product containing a new chemical or biological entity, which is currently not registered in the country or with any reference drug regulatory authority.
2. NPPA/NBPPA-2: For the first strength of a product containing a new fixed-dose combination of registered chemical or biological entities, with a new dosage form, new presentation, new formulation, new route of administration, new indication, dosage recommendation, or patient population that has not been previously approved for any reference pharmaceutical product and does not fall under post-approval changes/variations.
3. NPPA/NBPPA-3: Subsequent strengths of previously registered products.
ii. Biosimilar Product Application:
1. NBPPA-2: First strength of a biosimilar product with the same dosage form and route of administration.
2. NBPPA-3: Subsequent strengths of an already registered biosimilar.
iii. Generic Pharmaceutical Product Application (GPPA):
For bioequivalent products. It has the same dosage strength and form, route of administration, and condition of use as the reference pharmaceutical product.
iv. Identical Pharmaceutical Product Application (IPPA):
1. IPPA-1: Independent marketing authorization.
2. IPPA-2: Dependent on the principal product’s authorization.
b. Active Pharmaceutical Ingredient (API) Application: Required for APIs used as raw materials by manufacturers.
c. DOH-Use-Only Authorization: For products without valid marketing authorization, designated exclusively for DOH use.
d. Foreign Donation Authorization: Must comply with WHO guidelines, including a minimum shelf life and proper endorsement.
2. Post-Approval Changes
a. Post-Approval Change (PAC) Application:
i. Major Variations (MaV): Significant changes affecting safety, efficacy, and quality.
ii. Minor Variations (MiV): Changes with minimal impact, including:
1. MiV-Notification (MiV-N): Allows implementation before FDA acknowledgment for a year.
2. MiV-Prior Approval (MiV-PA): Requires FDA approval before implementation.
3.Product Categories
The Order categorizes pharmaceutical products and APIs, including:
a. Chemical Drugs
b. Biological Drugs
c. Radiopharmaceuticals
d. Homeopathic Drugs
e. Herbal Medicines
f. Traditional Medicines
g. Orphan Drugs
4.Classification Based on Safety:
a. Prescription Pharmaceutical Products: Require medical supervision and pose health risks.
b. Non-Prescription Pharmaceutical Products:
i. Pharmacist-Only Non-Prescription Products: Require pharmacist intervention for contraindications, interactions, or special handling, and must be obtained from licensed pharmacies under pharmacist supervision.
ii. General Sales Non-Prescription Products: Safe for sale without healthcare professional supervision, with easily recognizable contraindications and minimal risk of misuse.
5. Validity of CPR:
A CPR issued by the FDA shall have an initial validity of six years. The CPR may be renewed for an additional six or twelve years at the discretion of the applicant. Qualifications for the applicable validity periods shall follow the implementing guidelines.
Effectivity will be after the publication of the implementing guidelines. The administrative order can be found here: https://www.fda.gov.ph/wp-content/uploads/2024/09/Administrative-Order-No.-2024-0013.pdf