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, 3 rd Floor Annex bldg., FDA Compound Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City 24 July 2014 1
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 Center for Drug Regulation and Research 2
Republic of the Philippines Department of Health Food and Drug Administration Administrative Order No. 2013-0022 FDA Circular No. 2014-016 FOREIGN GMP CLEARANCE Center for Drug Regulation and Research 3
Administrative Order No. 2013-0022 Center for Drug Regulation and Research 4
Administrative Order No. 2013-0022 Center for Drug Regulation and Research 5
Administrative Order No. 2013-0022 Center for Drug Regulation and Research 6
Administrative Order No. 2013-0022 Center for Drug Regulation and Research 7
Administrative Order No. 2013-0022 Center for Drug Regulation and Research 8
FDA Circular No. 2014-016 Center for Drug Regulation and Research 9
Republic of the Philippines Department of Health Food and Drug Administration Administrative Order No. 2013-0022 FDA Circular No. 2014-016 FDA GMP CLEARANCE Center for Drug Regulation and Research 10
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 Center for Drug Regulation and Research 11
FDA GMP Clearance required for every manufacturer involved in the production of the drug Part of the requirement of drug registration Center for Drug Regulation and Research 12
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. Center for Drug Regulation and Research 13
Republic of the Philippines Department of Health Food and Drug Administration Administrative Order No. 2013-0022 FDA Circular No. 2014-016 IMPORTER’S RESPONSIBILITIES Center for Drug Regulation and Research 14
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
Republic of the Philippines Department of Health Food and Drug Administration Administrative Order No. 2013-0022 FDA Circular No. 2014-016 FDA OFFICES’ RESPONSIBILITIES Center for Drug Regulation and Research 16
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. Center for Drug Regulation and Research 17
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 Center for Drug Regulation and Research 18
AFO and PPO Assistance to FROO and CDRR (e.g. Travel authority) Center for Drug Regulation and Research 19
PAIR Receiving of applications Releasing of GMP Clearance/Notices/Denial Center for Drug Regulation and Research 20
LSSC Any legal support/sanction/appropriate action Center for Drug Regulation and Research 21
Republic of the Philippines Department of Health Food and Drug Administration Administrative Order No. 2013-0022 FDA Circular No. 2014-016 APPLICATION PROCESS Center for Drug Regulation and Research 22
Republic of the Philippines Department of Health Food and Drug Administration Foreign GMP Evidence Evaluation Foreign GMP Inspection INITIAL APPLICATION Center for Drug Regulation and Research 23
PAIR SUBMISSION Payment Electronic Submission EVALUATION REGULATORY DECISION RELEASING
GMP Evidence Evaluation SUBMISSION (1) Letter of Request EVALUATION REGULATORY DECISION RELEASING
GMP Evidence Evaluation SUBMISSION (2) Assessment Slip EVALUATION REGULATORY DECISION RELEASING
GMP Evidence Evaluation SUBMISSION (2) Assessment Slip EVALUATION REGULATORY DECISION RELEASING
GMP Evidence Evaluation SUBMISSION (3) GMP Evidence EVALUATION REGULATORY DECISION RELEASING
GMP Evidence Evaluation SUBMISSION (4) Annex B EVALUATION REGULATORY DECISION RELEASING
GMP Evidence Evaluation SUBMISSION (5) Annex E EVALUATION REGULATORY DECISION RELEASING
GMP Evidence Evaluation SUBMISSION (6) Annex C (for non-PIC/s) EVALUATION REGULATORY DECISION RELEASING
Payment: SUBMISSION Per application P10,000 + LRF EVALUATION REGULATORY DECISION RELEASING
CDRR SUBMISSION Storage of application Scheduling, assigning, and decking of EVALUATION applications REGULATORY DECISION RELEASING
GMP Evidence SUBMISSION GMP Dossier (where applicable) EVALUATION Other aspects of evaluation REGULATORY Completeness DECISION Fraudulent, misrepresentations, RELEASING falsified
GMP Clearance SUBMISSION Minor Deficiencies Notice to apply for Foreign Manufacturer EVALUATION GMP Inspection REGULATORY DECISION RELEASING
Information SUBMISSION Communication Technology Management Division (ICTMD) and EVALUATION PAIR Scanning Endorsement to PAIR for REGULATORY DECISION release RELEASING
Foreign GMP Inspection SUBMISSION (1) Letter of Request (2) Notice to Apply CORRESPONDENCE (3) Assessment Slip REGULATORY DECISION RELEASING
Foreign GMP Inspection SUBMISSION (4) Annex D CORRESPONDENCE REGULATORY DECISION RELEASING
Foreign GMP Inspection SUBMISSION (5) Annex C (where applicable) CORRESPONDENCE REGULATORY DECISION RELEASING
Payment: SUBMISSION P3,000.00 + LRF (per application per importer per site) CORRESPONDENCE REGULATORY DECISION RELEASING
FROO and applicant SUBMISSION Schedule of inspection Logistics CORRESPONDENCE REGULATORY DECISION RELEASING
CAPA SUBMISSION Recommendation for GMP Clearance Recommendation for CORRESPONDENCE Letter of Denial with re- application after six REGULATORY months DECISION RELEASING
Information SUBMISSION Communication Technology Management Division (ICTMD) and CORRESPONDENCE PAIR Scanning Endorsement to PAIR for REGULATORY DECISION release RELEASING
Republic of the Philippines Department of Health Food and Drug Administration Foreign GMP Evidence Evaluation Foreign GMP Inspection RENEWAL APPLICATION Center for Drug Regulation and Research 44
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 Center for Drug Regulation and Research 45
Renewal Application Payment: P2,000 + LRF Center for Drug Regulation and Research 46
Republic of the Philippines Department of Health Food and Drug Administration Administrative Order No. 2013-0022 FDA Circular No. 2014-016 REGULATORY ACTION Center for Drug Regulation and Research 47
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 Center for Drug Regulation and Research 48
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 Center for Drug Regulation and Research 49
Re-inspection of Foreign Manufacturer For re-inspection: the applicable procedure and application fees shall be adhered to Center for Drug Regulation and Research 50
Republic of the Philippines Department of Health Food and Drug Administration Administrative Order No. 2013-0022 FDA Circular No. 2014-016 DISCUSSION Center for Drug Regulation and Research 51
Issues and Concerns I. General Concerns II. GMP Evidence III. Submission of Application Center for Drug Regulation and Research 52
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