Food and Drug Administration (FDA) issued Administrative Order No. 2013 – 0022 also known as Guidelines for Current Good Manufacturing Practice (cGMP) Clearance and Inspection of Foreign Drug Manufacturers last August 13, 2013 signed by Kenneth Y. Hartigan-Go, the Acting Director General of the mentioned government authority. According to the rationale written on the Circular, the order seeks to ensure the compliance of all imported sources of pharmaceutical products with cGMP and to establish a separate database and coding system for applications of, and those compliant to cGMP.
Moreover, the issuance of this order provides supplementary guidelines to this Circular, seeks to identify or create specific units of FDA in implementing the regulation and to establish systems to ensure compliance of foreign pharmaceutical manufacturers with cGMP. This Circular only limits to establishments importing drugs, foreign drug and pharmaceutical manufacturers and those concerned offices of FDA.
According to the administrative order issued by FDA, all importers of drug products must obtain GMP clearance from their office for each of their foreign drug manufacturers occupied in any operations involved in production, thus FDA clearance is now a requirement for product registration. In addition, all offices that are in charge to monitor and re-evaluate GMP compliance of foreign drug manufacturer who sell or advertise their products for sale or distribution in the Philippines (like Center for Drug Regulation and Research (CDRR) and Field Regulatory Operations Office (FROO))are now given the authority and responsibility to do their corresponding jobs.
Their jobs include the assessment of the submitted applications of GMP clearance, recommendation to FROO for inspection those that have not provided satisfactory GMP evidence, maintenance of the database of foreign drug manufacturer compliant and non-compliant with cGMP, processing of applications for foreign GMP inspection, coordination with local establishment for logistics, handling schedules for foreign inspections, among others.
If any support is necessary for the implementation of this Circular, the Administration and Finance Office (AFO) and Policy and Planning Office (PPO) are ready to lend a helping hand.
There are currently five steps for the application of GMP clearance:
1. To submit your application for GMP clearance via GMP Evidence Evaluation and application for Product Registration of the earliest affected product and shall be submitted simultaneously.
2. Evaluation of GMP evidence application. The evaluation is based on completeness of the requirements and in accordance with the General Requirements for GMP Evidence Evaluation and other relevant standards, rules and regulations implemented by FDA. If, by any chance, it was found out that the application was falsified, CDRR will disapprove the application outright in accordance to Section 4, Article I, Book II of the IRR of Republic Act No, 9711 also known as Food and Drug Administration Act of 2009.
3. The decision on application for GMP Evidence Evaluation. During this time, it will be known if your application to cGMP is compliant or not. If it is compliant, it will be approved by CDRR, if otherwise, a notice shall be issued to the applicant stating that the applicant shall comply with ninety (90) working days upon receipt of the notice.
4. The coordination by the applicant with FROO for Foreign Drug Manufacturer GMP Inspection. During this time, FROO will notify the applicant for the logistics arrangement and schedule for inspection. Logistics arrangements are under the responsibility of the applicant, including visa application, plane ticket booking, other transportation requirements and expenses and hotel accommodations. Once the schedule of inspection is decided, the same shall be implemented not later than ninety (90) days from date of decision, unless other valid reason, it can be extended not later than thirty (30) days.
5. The decision after Foreign Drug Manufacturer GMP Inspection. If the inspection is compliant, FROO shall forward to CDRR the results of inspection and recommendation to issue a GMP clearance, otherwise, a Letter of Denial shall be forwarded to CDRR. Re-application shall be six (6) months after receipt of Letter of Denial by the importer.
Regulatory actions include cancellation of an issued GMP clearance, disapproval of applications for renewal of covered Certificate of Product Registration (CPR), and product recall and initiation for action for suspension or revocation of CPR. CDRR shall be the one responsible for informing affected drug importers of the cancellation of their GMP clearance and subsequent withdrawal from the market of all their products.
When re-inspection of manufacturing site is ordered, procedure provided and application fees shall be adhered to and all fees shall be shouldered by the concerned drug importers, following the arrangement of inspector’s fees. Fees shall be accomplished upfront upon submission of application and inspectors shall be paid their corresponding fees after receipt of notification from FDA but shall not be later than three (3) months from scheduled inspection date.
Full implementation of A.O. No. 2013-0022 will be on September 28, 2014. Failure to comply after the said date means denial of product application and revocation of CPR.
For companies who want to register their products and do not want to commit an unlawful act, you can contact Triple i Consulting. Our Regulatory Affairs Department can offer assistance in the preparation of all the documents needed, elude rejection and incomplete documents and minimize processing time.