I. RATIONALE
On 02 April 2020, FDA Circular No. 2020-012 was issued to provide guidelines for the registration of Drug Products Under Emergency Use (DEU) for the Coronavirus Disease 2019 (COVID-19). Said Circular was further amended by FDA Circular Nos. 2020- 012- A and 2020-012-B on 27 July 2020 and 26 August 2020, respectively.
The global search for an effective treatment against this emerging disease continues until today. The clinical management for treatment of suspected or confirmed cases is continuously being updated based on the Philippine Society for Microbiology and Infectious Diseases (PSMID) for the Clinical Management of Adult Patients with Suspected or Confirmed COVID-19 Infection. Also, R.A. No. 11494, otherwise known as the “Bayanihan to Recover As One Act” (“Bayanihan 2” for brevity) authorizes necessary and proper exercise of powers to ensure the availability of medicines in the supply chain [Section 4(dd)]. Thus, there is a need to reissue and update current regulations on the registration of drug products under emergency use to ensure access to the same at all times, regardless of the imposed quarantine restrictions. The need of the public for access to quality, safe, and effective medicines for the COVID-19 disease remains.
II. OBJECTIVE
This Circular aims to provide streamlined requirements and application process for the registration of Drug Products under Emergency Use (DEU) for COVID-19.
III. SCOPE AND COVERAGE
This Circular shall be applicable to all Marketing Authorization Holders (MAH) intending to manufacture and import/distribute the drug products listed in the PSMID Interim Guidelines on the Clinical Management of Adult Patients with Suspected or Confirmed COVID-19 Infection. These are the only considered Drug Products under Emergency Use (DEU) for the pandemic:
The drug product eligible for registration under DEU is as follows:
Generic Name Dosage Form and Strength
Tocilizumab 400 mg/ 20 mL Concentrate Solution for I.V. Infusion
200 mg/ 10 mL Concentrate Solution for I.V. Infusion
80 mg/ 4 mL Concentrate Solution for I.V. Infusion
162 mg/ 0.9 mL Solution for Injection (S.C.)
New applications for the registration of Chloroquine, Hydroxychloroquine, and Lopinavir + Ritonavir under DEU registration shall no longer be accepted.
Current stocks at the manufacturing level of those issued with Certificate of Product Registration (CPR) shall be exhausted for their approved indications within the given validity. No further extension shall be granted. Furthermore, the inventory of stocks on hand shall be submitted as required under FDA Circular No. 2020-013.
The list shall be updated following any change/s in the above-stated treatment guidelines.
IV. GUIDELINES
A. Eligibility Criteria
The DEU shall be locally manufactured or imported and distributed for the management of COVID-19 patients during the pandemic, following the PSMID Interim Guidelines.
B. Documentary Requirements
Only the following requirements shall be submitted by the MAHs:
1. Integrated Application Form (in excel and in pdf format)
2. Letter of Intent
3. Valid License to Operate of Drug Manufacturer/Repacker/Packer/Trader (for locally manufactured products) or Drug Importer (for imported products)
4. Certificate of Pharmaceutical Product or Certificate of Free Sale (for imported products)
5. List of countries where the product is marketed (for biologicals)
6. Certificate of Foreign Good Manufacturing Practice (GMP) Clearance duly issued by this Office and/or GMP Certificate issued by the national regulatory authority or other competent regulatory authority (for imported products)
7. Labeling Materials
8. Generic Labeling Exemption may be granted for products exceeding 12,000 units.
9. Product Composition/Formulation (Unit Dose and Batch Formulation)
10. Finished Product Technical Specifications
11. Finished Product Certificate of Analysis (CoA) and Batch Analysis
12. Stability Studies
13. Drug products with no stability studies shall be given an interim shelf-life of 6 months.
14. Proof of Payment (Official Receipt or Landbank Oncoll Payment Slip)
C. Application Process
There shall be no need for the scheduling of submission of applications under this Circular. Applications for the registration shall be under Emergency Use Classification and shall be submitted at the Food Drug Action Center (FDAC). Submission of applications may be done either:
Manual submission to FDAC. Submit the requirements in a flash drive at the FDAC – PACD. An Acknowledgement Receipt with a corresponding Document Tracking Number shall be issued to the applicant.
E-mail submission. The applicant shall submit the application through [email protected]. Guidance for e-mail submission shall be specified in a separate issuance.
D. Fees
The appropriate fees as prescribed under existing regulations shall apply, including the Legal Research Fund (LRF).
Application Type Fees
Emergency Use Registration Php 5,000.00 + LRF
Brand Name (if any) Php 500.00 + LRF per brand name
E. Validity of the Certificate of Product Registration (CPR)
The CPR shall be valid for one (1) year under Emergency Use Registration Status and is not subject for renewal registration. Automatic revocation of the CPR shall be imposed at the end of the pandemic.
F. Post-Approval Compliance
Post-Approval Compliance to the CPR shall be strictly required from the MAHs.
1. Post-Approval Commitments – shall be submitted within the CPR validity, or as prescribed below:
a. Post-Approval Stability Data of Commercial Batch/es for products without stability data submitted upon its registration
b. Commercial sample from the first batch of manufacture (local) or importation shall be submitted to this Office prior to distribution
c. Reference standards of the Active Pharmaceutical Ingredient/s (API) – submission shall be within five (5) working days from the CPR issuance
2. Post-Market Surveillance (PMS)
Health institutions (Hospitals, other Health Facilities) and Healthcare Professionals that shall use the products approved under this Circular shall be coordinate and submit to the respective suppliers/MAH for Adverse Drug Reaction (ADR) reports. The MAH shall be responsible for the submission of the ADR reports consistent with the latest issuance with this Office.
The MAH shall undertake the PMS activities in a separate issuance.
G. Supplemental Information
As interim measures for applications and transactions during the community quarantine, electronic signatures in documents shall be temporarily allowed. The requirement for notarized documents shall also be temporarily suspended. Instead, the applicant shall be required to submit a commitment letter for the submission of the notarized documents once available.
V. REPEALING CLAUSE
In the event that any provision or part of this Circular is declared unauthorized or rendered invalid by any court of law, those provisions not affected by such declaration shall remain valid and effective.
VI. EFFECTIVITY
This Circular shall take effect immediately and shall be effective until 31 December 2020, regardless of the level of the imposed quarantine restrictions due to COVID-19.
Attachment–>FDA-Circular-No.2020-028