FDA Circular: Registration of Stem Cell-Based Products
MANILA, Philippines - The Food and Drug Adminstration, pursuant to the Department of Health Administrative Order 2013-0012 known as “Rules and Regulations Governing the Accreditation of Health Facilities Engaging in Human Stem Cell and Stem-Cell Based or Cellular Therapies in the Philippines,” hereby stipulates the requirements and procedure for the registration of human stem cell-based products for the guidance and compliance of all concerned.
This circular, released Monday, July 8, does not cover cellular/cell-based therapeutic products intended to replace blood volume or alter the coagulative properties of blood.
A. DOCUMENTARY REQUIREMENTS FOR THE REGISTRATION OF HUMAN STEM CELL-BASED PRODUCTS
1. Notarized Application Form in duplicate (See Annex A below)
2. Electronic Copy (E-Copy) Affidavit
3. Copy of Certificate of Accreditation of facility handling stem cell-based product (issued by the Bureau of Health Facilities and Standards)
4. Copy of Marketing Authorization from the National Regulatory Authority (NRA) of the exporting country or the country of origin
5. List of countries where the product is already approved and the date(s) of approval
6. Copy of valid agreement between the manufacturer and the importer/distributor
7. Copy of GMP Certificate of the stem cell-based product manufacturer
8. Scientific evidence to support each claimed indication (at least one peer-reviewed and published)
9. Information on the product and its manufacture/production
9.1 Person(s) responsible for production, control and release of the product: name(s), position, Department and specimen signature
9.2 Formulation of the product
9.3 Information on the source of the stem cells and the raw materials used, including their specifications and the tests to demonstrate compliance with specifications
9.4 Specifications of the finished product and the tests to demonstrate conformance with specifications
9.5 Information on the method of manufacture, including the in-process control tests and limits, bulk and final product specifications, and test methods
9.6 Specifications of packaging materials (immediate and others), including the tests used to demonstrate compliance to specifications
10. Claimed shelf-life and stability studies undertaken to justify the shelf-life
11. Description of the cold-chain procedures employed (required storage conditions, transport conditions and storage in distribution outlets
12. Copy of labeling materials (3 copies). For allogeneic stem cell products, include product information on the following: indications and directions for use, storage conditions and description of the immediate packaging as well as secondary packaging, if any
13. Certificate of Analysis of at least one batch of product
14. Name of the person who will be responsible for any eventuality resulting from use of the product
16. DVD-R of the requirements 1-15
The FDA reserves the right to require submission of any other document that it deems necessary for the evaluation of the product.
B. PROCEDURE FOR THE REGISTRATION OF STEM CELL-BASED PRODUCTS
The basic procedure for the registration of drug products shall be followed for the registration of stem cell-based products. Transactions pertaining to registration shall be made every Tuesday and Wednesday only.
1.The applicant shall proceed to the FDA cashier with the accomplished Assessment slip and amount required for registration
(The fee for registration of a drug product under monitored release plus legal research fund of 1% or Php 10.00, whichever is higher, shall be charged for registration of stem cell-based products)
2. The required documents and the proof of payment shall be submitted to the receiving section of the Center for Drug Regulation and Research (CDRR)
3. The applicant receives the duplicate of the Notarized Application Form where the Routing Slip Number (RSN) is stamped by the CDRR staff.
4. Follow-up may be entertained after 60 working days.
Test tube and pipette image from Shutterstock