Title
Guidelines for CGMP Clearance of Foreign Drug Makers
Law
Fda Circular No. 2014-016
Decision Date
May 30, 2014
FDA Circular No. 2014-016 establishes guidelines for ensuring compliance with current Good Manufacturing Practices (cGMP) for foreign drug manufacturers, requiring them to obtain GMP clearance from the FDA prior to product registration and outlining the responsibilities of various FDA offices in the evaluation and inspection process.
administrative law
good manufacturing
practice

Legal basis and related issuances

  • Administrative Order No. 2013-0022 dated 13 August 2013 is the administrative basis for current CGMP/GMP clearance and inspection of foreign drug manufacturers.
  • FDA Circular No. 2014-016 provides implementing guidelines for Administrative Order No. 2013-0022, including systems for cGMP compliance and a database/coding system for compliance status.
  • Section 4, Article I, Book II of the IRR of Republic Act No. 9711 is cited for outright disapproval upon fraud, misrepresentation, falsification, or withholding of relevant data or information.
  • Annex F of Administrative Order No. 2013-0022 governs the fee amounts applied for GMP clearance and related activities.
  • Reiterated effectivity under Administrative Order No. 2013-0022 requires GMP clearance for product registration starting 28 September 2014.

Policy, purpose, and objectives

  • The Circular is issued to ensure compliance of all imported sources of pharmaceutical products with current Good Manufacturing Practices (cGMP).
  • The Circular is issued to establish a separate database and coding system for applications and compliance with cGMP.
  • The Circular sets supplementary/implementing guidelines to Administrative Order No. 2013-0022 for practical implementation.
  • The Circular identifies specific FDA units and assigns responsibilities for implementing the cGMP clearance and inspection system.
  • The Circular establishes systems aimed at ensuring compliance of foreign drug manufacturers with cGMP.

Scope and covered subjects

  • The Circular applies to all establishments importing drug products.
  • The Circular applies to foreign drug manufacturers whose products are imported for sale or distribution in the Philippines.
  • The Circular applies to concerned FDA offices involved in GMP clearance and inspections.
  • GMP clearance is required for each foreign drug manufacturer engaged in any and all operations involved in production for the importer’s registered products.
  • The Circular governs the FDA processes for GMP clearance, foreign GMP inspection, database management, and issuance of GMP Clearance or Letter of Denial.

GMP clearance as registration requirement

  • Prior to registration, all importers of drug products must obtain GMP clearance from FDA for each of their foreign drug manufacturer(s) engaged in production operations.
  • GMP clearance from FDA is declared a requirement for product registration.
  • CDRR evaluates GMP evidence submitted by applicants and issues GMP clearance when the manufacturing site is found compliant to cGMP.
  • If GMP evidence is not satisfactory, a Notice is issued requiring a foreign manufacturing site inspection before clearance may be granted.
  • GMP clearance decisions are coordinated between CDRR and FROO, with inspection conducted by FROO and clearance/denial communicated through CDRR.

Responsibilities by FDA offices

  • CDRR is responsible to re-evaluate and monitor GMP compliance of foreign drug manufacturers that sell or offer products for sale or distribute in the Philippines.
  • CDRR responsibilities include:
    • Assessing submitted applications for GMP Clearance.
    • Recommending to FROO inspection for applications that have not provided satisfactory GMP evidence.
    • Maintaining the database of foreign drug manufacturers that are compliant and noncompliant with cGMP.
    • Maintaining records of reports related to foreign inspections.
    • Maintaining the database of imported drug products with GMP Clearance.
    • Referring to FROO any event requiring inspection.
    • Issuing GMP Clearance / Letter of Denial.
  • FROO responsibilities include:
    • Processing applications for Foreign GMP Inspection.
    • Coordinating with the local establishment for logistics.
    • Handling scheduling of foreign inspections.
    • Conducting foreign GMP inspection.
    • Forwarding to CDRR inspection results with a recommendation for issuance of GMP Clearance or Letter of Denial.
  • The Administration and Finance Office (AFO) and the Policy and Planning Office provide necessary and appropriate support for implementation.

Application, evidence evaluation, and decisions

  • Applicants must submit application for GMP Clearance via GMP Evidence Evaluation and the application for Product Registration of the earliest affected product simultaneously.
  • Applicants must follow the current submission process required by the latest FDA issuance applicable to the submission of applications.
  • Evaluation of GMP evidence is based on completeness of requirements and in accordance with General Requirements for GMP Evidence Evaluation and other relevant FDA GMP evidence standards, rules, and regulations.
  • If CDRR finds that an applicant company fraudulently filed or misrepresented, falsified, or withheld relevant data or information, CDRR shall disapprove the application outright under Section 4, Article I, Book II of the IRR of Republic Act No. 9711.
  • If fraud or misrepresentation is found, CDRR may recommend appropriate legal actions to the LSSC.
  • If the manufacturing site is found compliant to current Good Manufacturing Practices (cGMP), CDRR shall issue a GMP Clearance with validity as provided under Section VII, (C2) of A.O. No. 2013-0022.
  • If the manufacturing site lacks satisfactory evidence of cGMP compliance, CDRR issues a Notice to the applicant with a copy furnished to FROO, requiring foreign manufacturing site inspection.
  • Upon receipt of the Notice, the applicant must comply within ninety (90) working days by filing an Application Form for Foreign Drug Manufacturer GMP Inspection and paying the corresponding fees following current FDA procedures.
  • The applicant must include a copy of the Notice in the foreign inspection application.

Foreign GMP inspection coordination and timelines

  • After FROO receives the foreign inspection application, FROO notifies the applicant for logistics arrangements and the inspection schedule.
  • The applicant’s logistics responsibilities include:
    • Visa application, when needed.
    • Plane ticket booking.
    • Other transportation requirements and expenses.
    • Hotel accommodations.
  • After scheduling is decided, the inspection must be implemented not later than ninety (90) days from the date of decision.
  • The inspection schedule may be extended only for justifiable reason, and any extension must not exceed thirty (30) days.
  • If the inspection is not implemented for reasons imputable to the applicant, the inspection is deemed abandoned.
  • If the inspection is deemed abandoned, FROO proceeds to recommend disapproval of the application for registration covering the importer’s drug product.

Post-inspection outcomes and re-application

  • If inspection results find the manufacturing site compliant to cGMP, FROO forwards results and recommendation to CDRR to issue GMP Clearance.
  • If inspection does not find compliance, or if inspection is declared abandoned under the deemed-abandoned rule, FROO forwards a recommendation for Letter of Denial to CDRR.
  • CDRR notifies the applicant of its decision after receiving inspection results/recommendations.
  • After a Letter of Denial, the importer may re-apply six (6) months after receipt of the Letter of Denial by the importer.

Renewal and regulatory triggers

  • Importers must re-apply three (3) months before the expiration of the issued GMP Clearance.
  • Renewal applications must submit the requirements under Initial Application and attach a copy of the latest GMP Clearance Letter.
  • If GMP clearance expires without renewal applications, CDRR takes regulatory actions as provided under the Circular’s regulatory actions framework.
  • FDA regulatory action applies when triggers require protection and promotion of public health.
  • Triggers include situations where product quality, safety, or efficacy is compromised, such as:
    • Cancellation by the originating country regulatory authority of authorization.
    • Withdrawal from the market due to safety, efficacy, or quality issues.
  • Regulatory actions include:
    • Cancellation of an issued GMP Clearance.
    • Disapproval of applications for renewal of covered CPRs.
    • Product recall.
    • Initiation of action for suspension or revocation of CPR.
  • When regulatory action is initiated, CDRR informs all affected/involved drug importers of the cancellation of GMP clearance and the subsequent withdrawal from the market of all affected/involved products.
  • When re-inspection of the manufacturing site is ordered, the applicable procedure and application fees follow the same framework, and inspection fees and other required expenses are shouldered by the concerned drug importers through the fee-sharing/special arrangement system.

Fees and inspection cost rules

  • Fee amounts are governed by Annex F of Administrative Order No. 2013-0022.
  • Initial GMP clearance application fees are PHP 5,000.00 (per importer per manufacturer per site) plus LRF plus PHP 5,000.00 (FGC Unit Review) plus LRF.
  • Renewal GMP clearance application fees are PHP 2,000.00 plus LRF.
  • Re-issuance of GMP clearance fees are PHP 1,000.00 plus LRF.
  • If recommended for foreign GMP inspection, the foreign inspection application fee is PHP 3,000.00 plus LRF (per application per importer per site).
  • Inspector’s fees are:
    • ASEAN: US$3,500.00 + UNDP-DSA*.
    • Asia Pacific: US$7,000.00 + UNDP-DSA*.
    • Others: US$10,500.00 + UNDP-DSA*.
  • UNDP-DSA is per inspector; the fixed fee is per inspection.
  • Accommodations, travel (if necessary), and other incurred fees are accomplished by the importer(s).
  • Foreign inspection fee is paid upfront upon submission of the foreign inspection application.
  • The inspector is paid the inspector’s fees after receipt of FDA notification, but no later than three (3) months from the scheduled inspection date.
  • Special arrangements for inspection may be applied for, subject to CDRR approval, for:
    • Same foreign manufacturer for multiple importers.
    • Multiple foreign manufacturers in the same vicinity of a single importer.
    • Multiple foreign manufacturers in the same vicinity of multiple importers.
    • Other situations that may arise.
  • Sharing of inspector’s fees and other incurred fees is allowed, but the division is outside FDA jurisdiction and handled internally by the multiple importers.
  • The foreign inspection application fee must be paid on a per application per importer basis even when fee sharing is used.

Effectivity, transitory implementation, and product rules

  • Full implementation of Administrative Order No. 2013-0022 is required on 28 September 2014.
  • After 28 September 2014, all initial and renewal applications for product registration, including all existing products, require valid GMP Clearance from FDA.
  • Failure to comply with the GMP clearance requirement results in denial of the product application and subsequent revocation of the CPR.

Repeal, separability, and revocation

  • Provisions of previous FDA circulars and memoranda inconsistent with FDA Circular No. 2014-016 are withdrawn, repealed, and/or revoked accordingly.
  • If any part, term, or provision of the Circular is declared contrary to law or unconstitutional, other provisions not affected remain in force and effect.

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