Advanced Operating Models
Sep 28, 2016

China Food and Drug Administration (CFDA) bringing CMC regulatory compliance to the forefront

Life science companies are experiencing unprecedented pressure to demonstrate chemistry, manufacturing, and controls (CMC) regulatory compliance across their global product portfolios and supply chains, and to understand and remediate any gaps in order to ensure products are manufactured to the standards and specifications outlined in the registered regulatory documentation.

Industry data suggests that companies undergoing consent decrees as a result of systemic CMC regulatory non-compliance have reported a financial impact of over $2 billion across litigation, penalties, stock value, brand perception, third-party controls, and product recalls.

The China Food and Drug Administration (CFDA) recently announced an initiative that aims to “standardize manufacture process supervision and ensure the safety of public drug use." Publishing a draft version on August 11, 2016 for public comments by September 10, the CFDA establishes a tight timeline for “manufacture process verification" that applies to all products registered in the country.

Each manufacturing site is expected to complete a self-audit of each manufacturing process and to finalize and submit a report to the relevant provincial government body by October 1, 2016. This is in advance of the CFDA commencing unannounced inspections of drug manufacturers as of November 1, 2016.

The purpose of this process is to determine whether the actual manufacturing process for a medicine is consistent with manufacturing processes approved by the food and drug regulatory authorities.

If any discrepancies within a manufacturing process are shown to have an effect on drug quality after research and validation, drug manufacturers are obliged to cease manufacture immediately. During the agency inspection, if the actual manufacturing processes are found to be inconsistent with those approved by the food and drug regulatory authorities, the drugs will be deemed to be fake drugs for disposal in accordance with the stipulations of Clause 2 of Article 48 of the Drug Control Law of the People's Republic of China. The regulatory authorities will subsequently apply punishment in accordance with the provisions of Article 74 of Drug Administration Law of the People's Republic of China, and publicly disclose the legal representatives and personnel responsible at the enterprises concerned.

The recent steps taken by the CFDA to ensure CMC regulatory compliance are indicative of a growing trend in the industry—that is, to inspect and apply punitive action to companies that fail to ensure that their products are manufactured, tested, and released to the standards registered at the local Board of Health. Given that the potential consequences of non-compliance range from legal sanctions to consent decree, liability, damage to brand, failed business strategy, and risk to patient safety, it seems that the question for most life sciences companies is “when," not “if," CMC regulatory compliance should be treated as a priority.

About the author

Dr. Ivan Fisher

Dr. Ivan Fisher

Assistant Vice President, Regulatory Affairs

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