China votes through medicine traceability scheme

Chinese lawmakers have voted to adopt wide-ranging changes to its medicines regulatory framework, including the introduction of a new medicine traceability system.

The updates to the country’s drug administration law were approved at the latest bimonthly meeting of the National People's Congress (NPC) Standing Committee yesterday, according to the Xinhua news agency.

The revisions – which represent the first update to the drug administration law since 2001 – are due to come into effect on December 1.

China’s traceability system isn’t the finished article yet, but is starting to come into focus thanks to guidance documents published this year that lay out the broad strokes of the framework.

Liu Pei, director of policy and regulation at the National Medical Products Administration (NMPA), told a press conference that the system would be central to ensuring drug safety and quality, preventing counterfeit and substandard drugs from entering the legal supply chain, and making recalls quicker and more efficient.

The plan is to require unique identifier codes to each minimum packaging unit of a medicine to allow it to tracked and verified within the supply chain, which is a similar approach to that adopted in Europe, the US as well as a number of other jurisdictions around the world.

The machine- and human-readable 20-digit Drug Traceability Code (DTC) – which can be provided by any organisation that adheres to a standard known as ISO /IEC 15459 – will be use as a building block to build a traceability framework based on “a series of…technical standards.”

The intention is to require aggregation data to be collected and shared with the authorities, in other words linking the individually coded medicine packs with the cartons, cases, and/or pallets used to ship them.

There is still no clear indication as to the overall structure of the system however, for example if it involves an ‘end-to-end’ approach used in Europe – with codes added at the point of manufacture and checked at the point of dispensing via a central hub – or a pedigree-like system akin to that envisages in the USA that will track pack transactions as they move through the supply chain.

Liu described the proposed system as a “retrospective collaborative platform” but there was no additional colour on the structure, which is expected to be spelled out in future guidance. Time is running out however if China is to meet its previously-announced objective of a framework system in 2020 with implementation three to five years later.

China went down the route of trying to use unique identifiers on medicine packs to allow traceability once before, but abandoned this older system – which was based on a platform developed by Alibaba subsidiary Ali Health – three years ago amid opposition from the drug industry.

Tougher penalties

Aside from the traceability elements, the changes to the drug administration law also include tougher punishments for those found guilty of producing falsified or substandard medicines, raising the maximum fine from 2-5 to 15-30 times earnings, as well as increasing the powers of enforcement agencies to shut down offending companies.

Regulatory authorities who fail to take sufficiently robust action against counterfeit or substandard medicines will also face greater penalties.

The new law also sets out specific cases – including producing and selling counterfeit or substandard drugs for pregnant women and children – where even more robust punishment can be levied.

Other changes include repealing a clause in the law that mean imported drugs that have been approved in other countries but not in China are treated as being counterfeit.

The change which was made “in response to the concerns of the people,” according to Liu, who stressed however that they would still be considered unapproved drugs in China under the new law unless import permission is granted.

Online sales

The revised law also introduces a preliminary framework for online sales of prescription medicines, as China wrestles with the competing demands of improving medicines access and preserving patient safety.

Liu said some classes of specialty drugs will not be allowed to be sold online, but added that there was room for “practical exploration” to refine the regulations for online medicine sales going forward.

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