HONG KONG – In the wake of a couple of incidents that have highlighted holes in China’s drug traceability and distribution systems, the country’s drug regulation has put forward a series of regulatory revisions.

The CFDA recently promulgated a revised Good Supply Practice for Pharmaceutical Products (GSP) to strengthen drug traceability and improve the country’s pharmaceutical supply chain, particularly for products that require refrigeration, such as vaccines.

“It makes several changes, mainly in two ways, to the previous version, as response to the two main incidents in the drug supply recently,” Zhu Min, a lawyer with Han Kun Law Offices, told BioWorld Asia.

The changes focus on two key areas: tracing and distribution.

In terms of drug tracing, the updated rules require distributors to establish a tracing system that can be used to “search for, and find information on, the source of drugs, distribution of drugs and responsible parties.”

An existing electronic drug supervision code is among those measures, but updated rules change the description of the purpose of the code from “drug electronic supervision” to “drug traceability.” At the same time, the new rules remove a requirement calling specifically for the use of such an electronic coding system.

“In this way, the CFDA has shown that it attaches great importance to drug tracing, but that the methods for drug tracing shall no longer be restricted to a drug-coding system,” said Zhu.

In February, Chinese officials stopped the use of a drug monitoring system that was owned by the government but run by Alibaba Health Information Technology Ltd., a subsidiary of Alibaba Group Holding Ltd. The move followed industry complaints and a lawsuit about the role of the private company in the mandated government-owned system.

The CFDA stepped in later to improve the tracing system and said it will transfer responsibility for running the traceability program to a nonprofit third party. With a strong technology background, Ali Health is still seen as the leading candidate to become that “nonprofit third party” that would manage the system.

It is unclear, however, how China will move forward to identify the sources of drugs and trace them through the system using the revised GSP. Zhu said he expects that, for the time being, the existing digital coding system should be efficient enough.

“The coding system is not a bad thing, and I believe the intention of the CFDA is good. The system could largely help solve the traceability issue. Before the digital code, pharmaceutical products did not have their own tracing system. They had a barcode, same as all other goods, from the General Administration of Quality Supervision, Inspection and Quarantine,” said Zhu. “However, considering its characteristic, we should implement a separate and efficient channel for tracing drugs.

“Also, some drug distributors have already followed the CFDA’s [lead] and installed digital coding terminals in their stores, which cost them a lot. They do not deserve to suffer the loss.”

On July 12, a new tracing platform from Ali Health went online. Based on the original medicine electronic supervision codes, the new platform is “open and market-oriented,” according to the company.

The other major area of focus for this update to China’s GSP regulation for pharmaceuticals is distribution.

The rules now include stricter requirements on the personnel and equipment required to store, transport and distribute drugs that require cold chains, with a focus on vaccines.

A series of scandals over the last couple of years have highlighted the dangers of distributing expired vaccines.

In a scandal that surfaced earlier this year, police in the eastern province of Shandong arrested a former pharmacist and her daughter, a medical school graduate, for illegally selling vaccines that had been improperly stored or had expired. The sales added up to more than ¥570 million (US$87.5 million) since 2011 and spanned 24 out of the country’s 34 provincial-level regions.

The new rules specifically state qualifications for vaccine delivery staff and clearly stipulate that vaccine storage and transportation facilities and equipment should be appropriately refrigerated.

“These changes are regarded as a response to a recent incident involving vaccines that engulfed the sector earlier this year,” said Chen Jian, who works at the Biopharmaceutical Product Division at the Wuhan Center for Disease Prevention and Control. “Before, the CFDA only required firms with a vaccine distribution business to have cold chain management capacity; now it extends to vaccine manufacturers as well as all parties involved in the distribution.”

“Both incidents have had a huge impact on the development of the pharmaceutical sector and we can see the CFDA’s efforts to fix the problems,” added Han Kun’s Zhu.

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