SLIDE 1 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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SLIDE 2 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
Center for Drug Regulation and Research 2
SLIDE 3 Republic of the Philippines Department of Health Food and Drug Administration
Center for Drug Regulation and Research 3
FOREIGN GMP CLEARANCE
Administrative Order No. 2013-0022 FDA Circular No. 2014-016
SLIDE 4 Administrative Order No. 2013-0022
Center for Drug Regulation and Research 4
SLIDE 5 Administrative Order No. 2013-0022
Center for Drug Regulation and Research 5
SLIDE 6 Administrative Order No. 2013-0022
Center for Drug Regulation and Research 6
SLIDE 7 Administrative Order No. 2013-0022
Center for Drug Regulation and Research 7
SLIDE 8 Administrative Order No. 2013-0022
Center for Drug Regulation and Research 8
SLIDE 9 FDA Circular No. 2014-016
Center for Drug Regulation and Research 9
SLIDE 10 Republic of the Philippines Department of Health Food and Drug Administration
Center for Drug Regulation and Research 10
FDA GMP CLEARANCE
Administrative Order No. 2013-0022 FDA Circular No. 2014-016
SLIDE 11 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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SLIDE 12 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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SLIDE 13 Manufacturer
An establishment engaged in any and all
- perations 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
- r 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.
Center for Drug Regulation and Research 13
SLIDE 14 Republic of the Philippines Department of Health Food and Drug Administration
Center for Drug Regulation and Research 14
IMPORTER’S RESPONSIBILITIES
Administrative Order No. 2013-0022 FDA Circular No. 2014-016
SLIDE 15 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
Center for Drug Regulation and Research 15
SLIDE 16 Republic of the Philippines Department of Health Food and Drug Administration
Center for Drug Regulation and Research 16
FDA OFFICES’ RESPONSIBILITIES
Administrative Order No. 2013-0022 FDA Circular No. 2014-016
SLIDE 17 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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SLIDE 18 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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SLIDE 19 AFO and PPO
Assistance to FROO and CDRR (e.g. Travel authority)
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SLIDE 20 PAIR
Receiving of applications Releasing of GMP Clearance/Notices/Denial
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SLIDE 21 LSSC
Any legal support/sanction/appropriate action
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SLIDE 22 Republic of the Philippines Department of Health Food and Drug Administration
Center for Drug Regulation and Research 22
APPLICATION PROCESS
Administrative Order No. 2013-0022 FDA Circular No. 2014-016
SLIDE 23 Republic of the Philippines Department of Health Food and Drug Administration
Center for Drug Regulation and Research 23
INITIAL APPLICATION
Foreign GMP Evidence Evaluation Foreign GMP Inspection
SLIDE 24
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING PAIR Payment Electronic Submission
SLIDE 25
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING GMP Evidence Evaluation (1) Letter of Request
SLIDE 26
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING GMP Evidence Evaluation (2) Assessment Slip
SLIDE 27
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING GMP Evidence Evaluation (2) Assessment Slip
SLIDE 28
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING GMP Evidence Evaluation (3) GMP Evidence
SLIDE 29
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING GMP Evidence Evaluation (4) Annex B
SLIDE 30
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING GMP Evidence Evaluation (5) Annex E
SLIDE 31
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING GMP Evidence Evaluation (6) Annex C (for non-PIC/s)
SLIDE 32
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING Payment: Per application P10,000 + LRF
SLIDE 33
EVALUATION
SUBMISSION
REGULATORY DECISION
RELEASING CDRR Storage of application Scheduling, assigning, and decking of applications
SLIDE 34
EVALUATION
SUBMISSION REGULATORY DECISION
RELEASING GMP Evidence GMP Dossier (where applicable) Other aspects of evaluation Completeness Fraudulent, misrepresentations, falsified
SLIDE 35
EVALUATION SUBMISSION
REGULATORY DECISION
RELEASING GMP Clearance Minor Deficiencies Notice to apply for Foreign Manufacturer GMP Inspection
SLIDE 36
EVALUATION SUBMISSION REGULATORY DECISION
RELEASING
Information Communication Technology Management Division (ICTMD) and PAIR Scanning Endorsement to PAIR for release
SLIDE 37 CORRESPONDENCE
SUBMISSION
REGULATORY DECISION
RELEASING Foreign GMP Inspection (1) Letter of Request (2) Notice to Apply (3) Assessment Slip
SLIDE 38 CORRESPONDENCE
SUBMISSION
REGULATORY DECISION
RELEASING Foreign GMP Inspection (4) Annex D
SLIDE 39 CORRESPONDENCE
SUBMISSION
REGULATORY DECISION
RELEASING (5) Annex C (where applicable) Foreign GMP Inspection
SLIDE 40 CORRESPONDENCE
SUBMISSION
REGULATORY DECISION
RELEASING Payment: P3,000.00 + LRF (per application per importer per site)
SLIDE 41 CORRESPONDENCE
SUBMISSION REGULATORY DECISION
RELEASING FROO and applicant Schedule of inspection Logistics
SLIDE 42 CORRESPONDENCE
SUBMISSION
REGULATORY DECISION
RELEASING CAPA Recommendation for GMP Clearance Recommendation for Letter of Denial with re- application after six months
SLIDE 43 CORRESPONDENCE
SUBMISSION REGULATORY DECISION
RELEASING
Information Communication Technology Management Division (ICTMD) and PAIR Scanning Endorsement to PAIR for release
SLIDE 44 Republic of the Philippines Department of Health Food and Drug Administration
Center for Drug Regulation and Research 44
RENEWAL APPLICATION
Foreign GMP Evidence Evaluation Foreign GMP Inspection
SLIDE 45 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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SLIDE 46 Renewal Application
Payment: P2,000 + LRF
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SLIDE 47 Republic of the Philippines Department of Health Food and Drug Administration
Center for Drug Regulation and Research 47
REGULATORY ACTION
Administrative Order No. 2013-0022 FDA Circular No. 2014-016
SLIDE 48 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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SLIDE 49 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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SLIDE 50 Re-inspection of Foreign Manufacturer
For re-inspection: the applicable procedure and application fees shall be adhered to
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SLIDE 51 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
SLIDE 52 Issues and Concerns
I. General Concerns II. GMP Evidence III. Submission of Application
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SLIDE 53 General Concerns (1)
Center for Drug Regulation and Research 53
Are manufacturers of APIs included?
The priority for now are finished drug product manufacturers; but the future direction is to include API manufacturers
SLIDE 54 General Concerns (2)
Is the GMP Certification per product? Or per Manufacturing Site regardless of the number
Center for Drug Regulation and Research 54
GMP clearance is per site, indicating the specific line cleared
SLIDE 55 General Concerns (3)
If the foreign manufactured was found to be non-compliant to GMP after inspection, all products affected will be denied?
Center for Drug Regulation and Research 55
Yes
SLIDE 56 General Concerns (4)
What is your timeline in issuing GMP Clearance?
Center for Drug Regulation and Research 56
15-21 days for PIC/s; 30-45 days for Non-PIC/s
SLIDE 57 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?
Center for Drug Regulation and Research 57
No, the validity of GMP clearance remains at a maximum of 3 yrs or dependent on the GMP evidence if less than 3 yrs
SLIDE 58 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?
Center for Drug Regulation and Research 58
Validity will be 2 yrs, but still subject to review
SLIDE 59 GMP Evidence (2)
Are all requirements needed to be authenticated? Or notarized with signature will suffice?
Center for Drug Regulation and Research 59
following the AO, FDA prefers authenticated by regulatory agency; but territorial Phil consulate authentication may also be accepted
SLIDE 60 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.
Center for Drug Regulation and Research 60
Yes, along with the other annexes (B and E)
SLIDE 61 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?
Center for Drug Regulation and Research 61
Yes, though the tracking number must be quoted
SLIDE 62 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.
Center for Drug Regulation and Research 62
No, since even non-PIC/s countries may still be approved depending
- n the GMP dossier submitted or other supporting documents
SLIDE 63 Submission of Application (2)
Is evidence per site required? (Annex C GMP Dossier) Or is it required only for non-PIC/s countries?
Center for Drug Regulation and Research 63
GMP Evidence per site is required. Annex C is required for non-PIC/s countries
SLIDE 64 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?
Center for Drug Regulation and Research 64
It is considered as 2 sites, with 2 gmp clearances received through separate applications
SLIDE 65 Submission of Application (4)
Is there a plan for the application form be included in the integrated form?
Center for Drug Regulation and Research 65
May be included
SLIDE 66 Republic of the Philippines Department of Health Food and Drug Administration
Center for Drug Regulation and Research 66
