23 October 2021 – Following the recommendation of the Anti-Red Tape Authority (ARTA), the Food and Drug Administration (FDA) removed the No Objection Certificate requirement in the evaluation of Foreign Good Manufacturing Practice (GMP) Clearance applications for inspected manufacturing sites.
The current GMP (cGMP) Clearance is needed before foreign manufacturers, through their local importers, can register their drug products with the FDA to make them available for local commercial distribution.
In a letter dated 18 October 2021, Jesusa Joyce N. Cirunay, Director IV of the FDA Center for Drug Regulation and Research (CDRR), explained that the CDDR will no longer issue a Notice to Coordinate (NOC), thus the removal of the No Objection Certificate requirement in the evaluation of Foreign Good Manufacturing Practice (GMP) Clearance applications.
The Memorandum that stated the rule will be applied to all pending and incoming Foreign GMP Clearance applications.
Following this, revisions on the Quality Work Procedure (QWP) on the evaluation of Foreign GMP Clearance application are now underway.
Cirunay also said that the FDA will release an advisory on the non-issuance of NOC to applicants for Foreign GMP Clearance for inspected foreign drug manufacturing site to keep stakeholders informed.
Secretary Jeremiah Belgica, ARTA Director General, thanked the FDA for its willingness to improve its processes for the public and vowed that ARTA will return the same eagerness in supporting the agency for any of its streamlining needs.
“We recognize FDA’s commitment to making things better and easier for the people by simplifying its processes. We hope that the agency’s revisions of the QWP on the evaluation of Foreign GMP Clearance applications will give birth to a more streamlined and efficient process,” Sec. Belgica said.
“ARTA is always very eager to assist and support other agencies in streamlining their processes,” he added.
The issue stemmed from a complaint filed by a representative of a pharmaceutical trading company before ARTA on 23 August 2021 regarding the No Objection Certificate requirement.
The complainant said that the FDA requires subsequent importers to coordinate with the initial importer to get a No Objection Certificate. However, initial importers are then encouraged to charge exorbitant fees before releasing the said certificate. This could lead to outright dismissal to the prejudice and damage of subsequent importers.
In a hearing on 17 September 2021, Cirunay confirmed that the CDRR implemented the No Objection Certificate to promote cost sharing among importers. But while FDA Circular No. 2014-16 stipulates for the sharing of the inspector’s fees and other incurred fees, the division of expenses is outside the scope of FDA’s jurisdiction and the sharing of expenses should be discussed internally among the importers without FDA’s intervention.
In his letter to the FDA dated 11 October 2021, Sec. Belgica recommended the removal of the No Objection Certificate from existing importers in the application of a cGMP Clearance to remove the undue regulatory burden to the importers.