Republic of the Philippines Department of Health
Food and Drug Administration
Meeting on the Implementation of
Administrative Order No. 2013-
0022, FDA Circular No. 2013-023,
FDA Circular 2014-016
Center for Drug Regulation and Research
Field Regulatory Operations Office AVR, 3rd Floor Annex bldg., FDA Compound
Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City
24 July 2014
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Presentation Outline I. Foreign GMP Clearance
II. FDA GMP Clearance
III. Importer’s Responsibilities
IV. FDA Offices’ Responsibilities
V. GMP Application Process
VI. Regulatory Action
VII. Discussion
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Republic of the Philippines Department of Health
Food and Drug Administration
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FOREIGN GMP CLEARANCE
Administrative Order No. 2013-0022
FDA Circular No. 2014-016
Administrative Order No. 2013-0022
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Administrative Order No. 2013-0022
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Administrative Order No. 2013-0022
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Administrative Order No. 2013-0022
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Administrative Order No. 2013-0022
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FDA Circular No. 2014-016
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Republic of the Philippines Department of Health
Food and Drug Administration
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FDA GMP CLEARANCE
Administrative Order No. 2013-0022
FDA Circular No. 2014-016
Rationale
Importers – must provide an acceptable form of evidence to show that the drug is manufactured at an acceptable standard
this evidence must be periodically submitted and reviewed
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FDA GMP Clearance
required for every manufacturer involved in the production of the drug
Part of the requirement of drug registration
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Manufacturer An establishment engaged in any and all operations involved in the production of health products including preparation, processing, compounding, formulating, filling, packing, repacking, altering, ornamenting, finishing and labeling with the end in view of its storage sale or distribution: Provided, that the term shall not apply to the compounding and filling of prescriptions in drugstores and hospital pharmacies. A trader shall be categorized as a manufacturer.
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Republic of the Philippines Department of Health
Food and Drug Administration
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IMPORTER’S RESPONSIBILITIES
Administrative Order No. 2013-0022
FDA Circular No. 2014-016
Importer 1) Secure FDA GMP Clearance for each
manufacturer involved in the product prior to applying for registration of the product
2) Inform FDA on any changes on the foreign manufacturer that may have a direct or indirect impact on the product
3) Complete and timely submission of requirements
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Republic of the Philippines Department of Health
Food and Drug Administration
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FDA OFFICES’ RESPONSIBILITIES
Administrative Order No. 2013-0022
FDA Circular No. 2014-016
CDRR 1) Evaluation and verification;
2) Recommend to FROO for inspection;
3) maintain the databases (compliant to cGMP)
4) Maintain the records of reports related to foreign inspections;
5) Issue GMP Clearance /Letter of Denial.
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FROO 1) foreign GMP Inspection;
2) coordinate with the local establishment for logistics and scheduling;
3) forward to CDRR the result of inspection with recommendation; and
4) Committee decision
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AFO and PPO Assistance to FROO and CDRR (e.g. Travel authority)
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PAIR Receiving of applications
Releasing of GMP Clearance/Notices/Denial
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LSSC Any legal support/sanction/appropriate action
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Republic of the Philippines Department of Health
Food and Drug Administration
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APPLICATION PROCESS
Administrative Order No. 2013-0022
FDA Circular No. 2014-016
Republic of the Philippines Department of Health
Food and Drug Administration
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INITIAL APPLICATION
Foreign GMP Evidence Evaluation
Foreign GMP Inspection
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING
PAIR
Payment
Electronic Submission
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING
GMP Evidence Evaluation
(1) Letter of Request
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING
GMP Evidence Evaluation
(2) Assessment Slip
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING
GMP Evidence Evaluation
(2) Assessment Slip
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING
GMP Evidence Evaluation
(3) GMP Evidence
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING
GMP Evidence Evaluation
(4) Annex B
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING
GMP Evidence Evaluation
(5) Annex E
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING
GMP Evidence Evaluation
(6) Annex C (for non-PIC/s)
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING
Payment:
Per application
P10,000 + LRF
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING
CDRR
Storage of application
Scheduling, assigning, and decking of applications
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING
GMP Evidence
GMP Dossier (where applicable)
Other aspects of evaluation
Completeness
Fraudulent, misrepresentations, falsified
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING
GMP Clearance
Minor Deficiencies
Notice to apply for Foreign Manufacturer GMP Inspection
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING
Information Communication Technology Management Division (ICTMD) and PAIR
Scanning
Endorsement to PAIR for release
CORRESPONDENCE
SUBMISSION
REGULATORY DECISION
RELEASING
Foreign GMP Inspection
(1) Letter of Request
(2) Notice to Apply
(3) Assessment Slip
CORRESPONDENCE
SUBMISSION
REGULATORY DECISION
RELEASING
Foreign GMP Inspection
(4) Annex D
CORRESPONDENCE
SUBMISSION
REGULATORY DECISION
RELEASING
(5) Annex C (where applicable)
Foreign GMP Inspection
CORRESPONDENCE
SUBMISSION
REGULATORY DECISION
RELEASING
Payment:
P3,000.00 + LRF (per application per importer per site)
CORRESPONDENCE
SUBMISSION
REGULATORY DECISION
RELEASING
FROO and applicant
Schedule of inspection
Logistics
CORRESPONDENCE
SUBMISSION
REGULATORY DECISION
RELEASING
CAPA
Recommendation for GMP Clearance
Recommendation for Letter of Denial with re-application after six months
CORRESPONDENCE
SUBMISSION
REGULATORY DECISION
RELEASING
Information Communication Technology Management Division (ICTMD) and PAIR
Scanning
Endorsement to PAIR for release
Republic of the Philippines Department of Health
Food and Drug Administration
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RENEWAL APPLICATION
Foreign GMP Evidence Evaluation
Foreign GMP Inspection
Renewal Application 1) Letter of Request
2) GMP Evidence
3) Annex B
4) Annex C (for non-PIC/s countries)
5) Annex E
6) Copy of GMP Clearance
7) Assessment Slip
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Renewal Application Payment: P2,000 + LRF
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Republic of the Philippines Department of Health
Food and Drug Administration
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REGULATORY ACTION
Administrative Order No. 2013-0022
FDA Circular No. 2014-016
Triggers Any situations wherein the quality, safety and efficacy of a product has been compromised
cancellation by the regulatory authority of the originating country of the authorization
withdrawal from the market due to safety, efficacy or quality issues
Occurrence of ADEs
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Regulatory Action cancellation of an issued GMP Clearance;
disapproval of applications for renewal of covered CPRs;
product recall; and
suspension or revocation of CPR
Imposition of administrative fines
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Re-inspection of Foreign Manufacturer
For re-inspection:
the applicable procedure and application fees shall be adhered to
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Republic of the Philippines Department of Health
Food and Drug Administration
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DISCUSSION
Administrative Order No. 2013-0022
FDA Circular No. 2014-016
Issues and Concerns I. General Concerns
II. GMP Evidence
III. Submission of Application
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General Concerns (1)
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Are manufacturers of APIs
included?
General Concerns (2) Is the GMP Certification per product? Or per Manufacturing Site regardless of the number of products?
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General Concerns (3) If the foreign manufactured was found to be non-compliant to GMP after inspection, all products affected will be denied?
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General Concerns (4) What is your timeline in issuing GMP Clearance?
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General Concerns (5) The validity of GMP Clearance is 3 years while CPR is 5 years? Can we apply for GMP clearance along with the renewal of CPR which is 5 years?
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GMP Evidence (1) If in case we submitted a CPP as GMP evidence, what will be the validity, taking note that some CPPs do not have expiry date only issue date with note that inspection is done periodically every 2 years?
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GMP Evidence (2) Are all requirements needed to be authenticated? Or notarized with signature will suffice?
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GMP Evidence (3) Please confirm that for PIC/S member countries, the GMP Certificate or the CPP or the Manufacturing license/authorization issued for the manufacturer (where the product lines are indicated) will suffice. The importer will only submit any of the above documents and pay the required fees.
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GMP Evidence (4) Some Annex C documents will not be provided by the CMO directly to a company which contracted their services. Is there a mechanism by which the CMO can provide directly the documents to the Phil. FDA. Is there an established procedure for this? Or will the Phil. FDA be amenable to this procedure?
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Submission of Application (1)
Since our products are coming from non-PIC/s members can we directly proceed to FROO? To avoid additional waiting time of denial of our application and directly proceed to schedule for our Foreign Audit also to avoid additional charges since there were high percentage that CDRR will disapprove the desk top review.
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Submission of Application (2)
Is evidence per site required? (Annex C GMP Dossier) Or is it required only for non-PIC/s countries?
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Submission of Application (3)
If I have manufacturer A but it has 2 factories. Is it considered as 1 site or 2 sites?
If it is considered 2 sites, do we need to apply 2 GMP clearances? how do we apply, under one application or separately?
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Submission of Application (4)
Is there a plan for the application form be included in the integrated form?
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Republic of the Philippines Department of Health
Food and Drug Administration
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