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Website: www.fda.gov.ph  Email: info@fda.gov.ph  
 Republic of the Philippines  
Department of Health  
FOOD AND DRUG ADMINISTRATION  
 
 
 
FDA CIRCULAR  
No. _______________________  
 
 
SUBJECT:  Interim Guidelines on the Renewal of Current Good 
Manufacturing Practice (cGMP) Clearance of Foreign Drug 
Manufacturers  
 
 
I. RATIONALE/BACKGROUND  
 
Pursuant to Administrative Order (AO) No. 2013 -0022, entitled, “Guidelines 
for Current Good Manufacturing Practice (cGMP) Clearance and Inspection of 
Foreign Drug Manufacturers”, and its implementing guidelines, FDA Circular 
No. 2014 -016, the Food and Drug Administration (FDA) conducts inspections 
of foreign  drug manufacturers to ensure compliance with the principles of GMP.  
Apart from documentary evidence, on -site inspections, when determined by 
FDA, are required for securing a cGMP clearance prior to registration.  
 
In March 2020, the World Health Organizati on (WHO) declared COVID -19 a 
global pandemic. The FDA Philippines recognizes that this ongoing pandemic 
is not only affecting public health, but it also is posing a crisis in the 
pharmaceutical sector. Furthermore, this Public Health Emergency of 
Internati onal Concern imposes operational challenges and limitations, rendering 
foreign inspections not feasible. Conducting on -site inspections poses a clear 
health risk to the FDA GMP inspectorate.  
 
To ensure the welfare and protection of the Drug GMP Inspectora te Task Force 
while ensuring availability and access to essential drug products  amidst the 
COVID -19 pandemic, FDA Circular No. 2020 -020, entitled, “Interim 
Guidelines Governing the Issuance of a Permit to Register to Drug Importers 
for Foreign Drug Manufac turers”, was issued.  
 
On 20 August 2020, the FDA issued FDA Circular No. 2020 -024, entitled , 
“Updated Guidelines for Application of Authorizations at the Food and Drug 
Administration in Light of the Community Quarantine Declarations”, declaring 
that the c onduct of all foreign inspections for the year 2020 shall be deferred 
until further notice pending the lifting of the travel restrictions being imposed 
in the Philippines and other countries concerned.  
 
In light of the continuing global public health situ ation, this Circular is hereby 
issued to provide the interim guidelines on the renewal of cGMP clearance of 
foreign drug manufacturers to ensure the availability and access to drug 
products from foreign sources.  
  
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II. OBJECTIVES  
 
Considering the COVID -19 pandemic and consistent with the spirit and 
continuing policy of the government manifested in the pertinent objectives and 
the declared COVID -19 response and recovery interventions provided under 
Republic Act No. 11494 or the “Bayanihan to Recover As One A ct”, this 
Circular is being issued to provide the interim guidelines on the renewal of 
cGMP clearance of foreign drug manufacturers.  
 
 
III. SCOPE  
 
This Circular shall apply to all incoming and previously received foreign cGMP 
clearance renewal applications.  
 
 
IV. GUIDELINES  
 
A. Incoming Renewal Applications  
 
Renewal applications filed with the FDA shall be submitted in accordance 
with the following guidelines:  
 
1. Applicants shall follow the process of submission in accordance with 
the Food and Drug Action Center (FDAC) New Normal Operational 
Guidelines, as indicated in FDA Circular No. 2020 -026 or its latest 
issuance.  
2. The requirements  provided in AO No. 2013 -0022, FDA Circular No. 
2014 -016, and relat ed issuances shall be submitted as follows:  
a. Letter of Request  
b. GMP Evidence  
The acceptable GMP evidence issued by a competent authority listed 
may be in the form of:  
i. GMP Certificate (Certificate of GMP Compliance), or  
ii. WHO Certificate of Pharmaceutical Product; or  
iii. Manufacturer’s License or Manufacturing Authorization 
incor porating the specific medicinal product(s)/ dosage 
form(s).  
c. Annex B (Request for GMP Evidence Evaluation Form) of AO 
2013 -0022  
d. Annex C (GMP Evidence Dossier) of AO No. 2013 -0022 – for Non -
PIC/S  
e. Annex E (Affidavit of Undertaking) of AO No. 2013 -0022  
f. Assessm ent Slip  
3. The cGMP Clearances for Foreign Drug Manufacturers issued by the 
FDA of all incoming renewal applications covered by this Circular shall 
be extended until 31 December 2021. However, those applications with 
a longer validity than 31 December 2021 s hall be processed . 
  
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 B. Previously Received Renewal Applications  
 
The validity of cGMP Clearances for Foreign Drug Manufacturers issued 
by the FDA of all previously received renewal applications shall be 
extended until 31 December 2021. However, those applicat ions with a 
longer validity than 31 December 2021 shall be processed.  
 
An application for renewal of a cGMP clearance received after 31 December 
2021 shall be subject to a surcharge or penalty equivalent to twice the 
renewal cGMP clearance fee and an additional 10% per month or a fraction 
thereof of continuing non -submission of such application to a maximum of 
one hundred twenty (120) days. Any application for renewal of cGMP 
clearance filed after the 120 -day period shall be considered expired and the 
application shall be subject to a fee equivalent to the total surcharge or 
penalty plus the initial filing fee and the application shall undergo the initial 
filing and evaluation procedure. Further, the Center for Drug Regulation and 
Research shall take other regulatory actions as warranted.  
 
 
V. REPEALING AND SEPARABILITY CLAUSE  
 
Provisions in previous circulars and memoranda that are inconsistent with this 
Circular are hereby withdrawn, repealed and/or revoked accordingly.  
 
If any provision in this Circular, or application of such provision to any 
circumstances, is held invalid, the  remainder of the provisions in this Circular 
shall not be affected.  
  
 
VI. EFFECTIVITY  
 
This Circular is an interim guideline during the COVID -19 pandemic and shall 
take effect immediately and valid until 31 December 2021, unless sooner 
revoked.  
 
 
 
 
 
 ROLANDO ENRIQUE D. DOMINGO, MD  
Director General