China tightens quality standards for pharma distributors
pharmafile | July 2, 2013 | News story | Manufacturing and Production |Â Â China, FDA, GMP, GSPÂ
From 1 July new pharmaceutical distributors in China will be obliged to adhere to the country’s recently-issued Good Supply Practice (GSP) for medicines.
The recently-formed China Food and Drug Administration (CFDA) – which was set up to replace a group of agencies with overlapping responsibilities earlier this year after the State Food and Drug Administration (SFDA) was elevated to ministerial level – published the new GSP standards in January.
Under the new regulations, newly set-up pharmaceutical wholesalers – as well as companies that open additional warehouses or expand or renovate existing facilities – are required to apply for GSP accreditation within 30 days. If a subsequent regulatory inspection is passed the company is issued with a certificate that is valid for five years.
The July deadline also applies to established distributors dealing with vaccines, narcotic and psychotropic substances, anabolic agents and peptide hormones, and while these wholesalers can seek an extension they must be in compliance by the end of 2014 or face cancellation of their distribution licenses.
The new GSP standards – which were several years in the drafting stages – centre on the establishment of an effective quality control systems at distribution facilities. For example, they state that a dedicated team should be set up to handle quality control matters across the entire distribution chain.
Among the specific measures are that management of inventory must be computerised, stricter requirements met for cold chain and humidity control, and information management systems implemented to improve record-keeping, complaint-handling and the handling of product recalls and withdrawals.
The GSP also makes it clear that distributors should be prepared for China’s planned introduction of a traceability system, which should allow each pharmaceutical pack to be tracked through the supply chain using barcodes.
China has made no secret of the fact that one of the primary objectives of the GSP regulations is to force consolidation in the pharmaceutical wholesaling sector, which is enormously fragmented and complex with an estimated 13,000 licensed distributors.
It is likely that the costs of coming into compliance with the regulations will drive some small players out of the market or make them candidates for takeover by larger competitors.
China’s government has said it would like to see two or three large-scale, nationwide pharmaceutical distributors in operation by the end of 2015, when all distributors must be GSP-compliant, along with a number of mid-size players.
The introduction of the GSP requirements is the latest in a series of measures adopted by China in recent years to tighten up standards in its domestic pharmaceutical industry, which got into full swing after it adopted new rules on Good Manufacturing Practices in March 2011.
Phil Taylor
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