Simplified Chinese
The abolition of GMP certification has finally been finalized.
Release date:
2017-09-26
Author:
Excerpted from the International Chamber of Commerce
Source:
Excerpted from the International Chamber of Commerce
Abstract
According to sources, at the recently concluded National Symposium on Food and Drug Supervision, Deputy Director Wu Zhen delivered a speech reviewing drug regulatory efforts in the first half of 2017 and outlining new requirements and strategic directions for drug regulation in the second half of 2017.
In terms of regulatory approach: the focus should be on core business, with rigorous oversight and clear accountability. Provincial regulatory authorities are urged to shift away from an overemphasis on approvals at the expense of supervision, strengthening inspection and enforcement while reducing reliance on licensing and approval processes. This implies that many regulators will need to pivot their priorities toward frontline inspections. Going forward, GMP, GCP, GLP, and GSP certifications will be consolidated into a single certificate, and certification certificates will no longer be issued. The Dandelion Forum has previously seen extensive debate and discussion on the issue of this unified certification. Certification is merely a formal requirement; while GMP certification will be abolished, GMP requirements themselves will remain in force.
In terms of regulatory philosophy, the focus should shift from inspecting enterprises to inspecting product categories. Pre‑market on‑site inspections, compliance reviews of manufacturing processes, and post‑market oversight will all be conducted with a product‑category‑based approach, assessing the effective operation of the overall quality system and ensuring ongoing compliance.
In terms of regulatory measures, it is essential to fully leverage information from random inspections, monitoring, pricing data, and consumer complaints to identify potential issues. Inspections must be targeted, with thorough preparatory work conducted beforehand. For pharmaceutical manufacturers, establishing comprehensive drug dossiers is imperative. The past practice of conducting ad hoc, superficial inspections that failed to uncover real problems will inevitably be subject to rigorous scrutiny.
On the regulatory front, we will further strengthen the seamless coordination between inspections and investigations. This means that evidence gathered during inspections can be directly used as the basis for case handling, integrating inspection records with evidence collection and linking inspections to subsequent investigations. Such joint enforcement efforts will effectively prevent disjointed processes and hollow outcomes, ensuring that enterprises engaging in violations or illegal activities—particularly those harboring侥幸心理—are subjected to even stricter penalties.
On the regulatory enforcement front, penalties will be further tightened: any issues identified during inspections will be dealt with rigorously, with measures tailored to the severity of each case. For enterprises ordered to suspend production, the interval between re-inspections may be extended to one year, which will serve as a more stringent deterrent for many non‑compliant firms. According to reports, the State Administration is currently drafting regulations that hold individuals accountable, integrating financial sanctions, disqualification penalties, and criminal penalties to ensure that violators face severe punishment.
Regarding the regulatory workforce: the General Administration is considering formulating measures to establish a professional corps of inspectors.
This address was packed with substantive insights, outlining the marketing authorization holder’s strategic approach: centering inspections on product‑specific oversight and adopting a portfolio‑based framework. The Drug Production Division and the Inspection Bureau are collaborating on joint investigations, and the revocation of GMP certificates will now require a one‑year interval. Furthermore, provincial drug regulatory authorities are expected to assume full responsibility for overseeing pharmaceutical manufacturers. In my view, these principles are both innovative and clearly articulated.
On the issue of abolishing GMP certification, industry-wide debate has been ongoing for a long time. Although many media outlets have previously discussed it, this is the first time that such a position has been explicitly stated in an official meeting and address. Therefore, the abolition of GMP certification is now virtually certain—let’s wait and see!
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