Meeting on the Implementation of Administrative Order No. 2013- … GMP... · Meeting on the...

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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

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

FOREIGN GMP CLEARANCE

Administrative Order No. 2013-0022

FDA Circular No. 2014-016

FDA GMP CLEARANCE

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

FDA GMP Clearance

required for every manufacturer involved in the production of the drug

Part of the requirement of drug registration

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.

IMPORTER’S RESPONSIBILITIES

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

FDA OFFICES’ RESPONSIBILITIES

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.

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

AFO and PPO Assistance to FROO and CDRR (e.g. Travel authority)

PAIR Receiving of applications

Releasing of GMP Clearance/Notices/Denial

LSSC Any legal support/sanction/appropriate action

APPLICATION PROCESS

INITIAL APPLICATION

Foreign GMP Evidence Evaluation

Foreign GMP Inspection

EVALUATION

SUBMISSION

REGULATORY DECISION

RELEASING

Payment

Electronic Submission

EVALUATION

SUBMISSION

REGULATORY DECISION

RELEASING

GMP Evidence Evaluation

(1) Letter of Request

EVALUATION

SUBMISSION

REGULATORY DECISION

RELEASING

(2) Assessment Slip

EVALUATION

SUBMISSION

REGULATORY DECISION

RELEASING

(2) Assessment Slip

EVALUATION

SUBMISSION

REGULATORY DECISION

RELEASING

(3) GMP Evidence

EVALUATION

SUBMISSION

REGULATORY DECISION

RELEASING

(4) Annex B

EVALUATION

SUBMISSION

REGULATORY DECISION

RELEASING

(5) Annex E

EVALUATION

SUBMISSION

REGULATORY DECISION

RELEASING

(6) Annex C (for non-PIC/s)

EVALUATION

SUBMISSION

REGULATORY DECISION

RELEASING

Payment:

Per application

P10,000 + LRF

EVALUATION

SUBMISSION

REGULATORY DECISION

RELEASING

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

(1) Letter of Request

(2) Notice to Apply

(3) Assessment Slip

CORRESPONDENCE

SUBMISSION

REGULATORY DECISION

RELEASING

(4) Annex D

CORRESPONDENCE

SUBMISSION

REGULATORY DECISION

RELEASING

(5) Annex C (where applicable)

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

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

RENEWAL APPLICATION

Foreign GMP Evidence Evaluation

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

Renewal Application Payment: P2,000 + LRF

REGULATORY ACTION

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

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

Re-inspection of Foreign Manufacturer

For re-inspection:

the applicable procedure and application fees shall be adhered to

DISCUSSION

Issues and Concerns I. General Concerns

II. GMP Evidence

III. Submission of Application

General Concerns (1)

Are manufacturers of APIs

included?

General Concerns (2) Is the GMP Certification per product? Or per Manufacturing Site regardless of the number of products?

General Concerns (3) If the foreign manufactured was found to be non-compliant to GMP after inspection, all products affected will be denied?

General Concerns (4) What is your timeline in issuing GMP Clearance?

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?

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?

GMP Evidence (2) Are all requirements needed to be authenticated? Or notarized with signature will suffice?

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.

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?

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.

Is evidence per site required? (Annex C GMP Dossier) Or is it required only for non-PIC/s countries?

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?

Is there a plan for the application form be included in the integrated form?

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