Posted 26 April 2016
By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China Puts Hepatitis C, Cancer Drugs on Regulatory Approval Fast Track
China has granted priority review status to a clutch of drugs being developed by Western companies. The products affected by the actions include the expensive hepatitis C drugs from Gilead Sciences and other manufacturers that have transformed treatment of the disease in the West.
Versions of Gilead’s blockbuster hepatitis C drug Sovaldi and Harvoni were granted priority review status as part of a bulk action by China’s Center for Drug Evaluation (CDE). The action also conferred the same regulatory benefits on rival products from AbbVie, Bristol-Myers Squibb and Johnson & Johnson’s Janssen Pharmaceuticals. CDE took the action after ruling that the antivirals have obvious clinical advantages over existing treatment options.
In doing so, CDE has potentially shortened the time it will take for the estimated 10 million hepatitis C patients in China to gain access to the interferon-free antivirals. As it stands, hepatitis C patients in China must travel overseas if they want to be treated with anything other than earlier generations of injectable treatments, which are less effective and have more side effects than Sovaldi and Harvoni.
Days after issuing the hepatitis C notice, CDE granted priority-review status to a pair of cancer drugs. Lenalidomide, a myeloma therapy sold by Celgene as Revlimid, and Boehringer Ingelheim’s non-small cell lung cancer drug Afatinib are the affected products. CDE granted Afatinib the status in the belief that it has obvious clinical advantages over the first generation of epidermal growth factor receptor tyrosine-kinase inhibitors.
The companies are the first foreign drugmakers to receive priority-review status since the pathway was adopted, The Wall Street Journal reports. China has adopted the pathway to stop its regulatory backlog from delaying the approval of drugs that are needed by its population.
Hepatitis C Notice, Cancer Notice (both Chinese), WSJ
Surprise CFDA Inspections Find Fault with Production Practices at Local Plants
The program of unannounced plant inspections initiated by the China Food and Drug Administration (CFDA) has identified failings at three local companies. CFDA has ordered the halting of production, recall of products and initiation of criminal investigations after uncovering the alleged failings.
Regulatory officials found a variety of failings during the surprise inspections. One company, Guizhou Shouxian Pharmaceutical, is accused of continuing to operate its production plant despite its good manufacturing practice (GMP) certificate expiring in July. CFDA has ordered the company to seal up its inventory and recall the products it has already sold.
The other two companies, Hebei Yongfeng Yaoye and Gansu Dadeli Pharmaceutical, are reported to have fallen short of GMPs in multiple areas. At Hebei Yongfeng Yaoye, inspectors found fault with the sterilization process and recordkeeping, failings CFDA deemed serious enough to order the company to stop production.
CFDA Notice (Chinese), Reuters
CFDA Advances ‘Social Credit’ System in Alliance with Tax Department
The CFDA has entered into an alliance with the country’s tax department to set up a “social credit” system. CFDA is presenting the credit system as a way to build a more complete picture of the corporate integrity of the businesses it regulates, a resource it sees as helping focus its efforts on high-risk organizations.
By partnering with the Chinese state tax administration, CFDA is looking to gain access to resources and capabilities to set up and build out the database of drug company credit ratings it proposed late last year. CFDA will work with the tax department to set up a credit information sharing platform. The system will enable the two organizations to pool information on companies. As well as the financial information associated with credit scores in the West, the CFDA database will include details of the regulatory status of each company.
Full details of what CFDA plans to track are yet to emerge. In the government briefing document that outlined the social credit system, the approaches of companies to drug safety and security were noted as important factors. The document also listed drug counterfeiting and falsification as activities that the social credit system would monitor. Companies that are assigned a poor credit score based on this mix of financial and regulatory factors will face punishments, although, again, details of the full scope of what will happen to such organizations are yet to emerge.
CFDA has also suggested that companies that achieve a good credit score on the proposed A to D ranking system could enjoy certain benefits. In a release to unveil the alliance with the state tax department, CFDA refers to a “green channel” that will provide convenient services to organizations deemed to be trustworthy by the system. In contrast, CFDA and the tax department will adopt stricter auditing and inspection practices for companies with poor credit scores. This suggests the system could enable a more risk-based approach to regulatory oversight.
The picture should become clearer in the coming years. CFDA is aiming to have a complete social credit system in place by 2020. Before then, the system will go through several iterations, starting with the creation of the basic framework for the platform. The regulator is working to have this framework in place by the end the year, after which it will start to populate the repository with data. The database is part of a broader initiative to assign a credit rating based on financial security and compliance to social norms to each Chinese citizen, a program branded as “Orwellian” by its critics.
CFDA Notice (Chinese)
Pakistan Considers Legal Action Against Merck Serono, Sandoz over Drug Pricing
Pakistan is considering taking legal action against companies including Merck Serono and Sandoz for allegedly violating drug pricing legislation. The proposed prosecutions follow the seizure of products by Federal Inspectors of Drugs (FID) on the grounds that the affected manufacturers had raised their prices without permission from the government.
Officials at the Drug Pricing Committee (DPC) are set to consider what action to take at a meeting in the first week of May. The topic was put on the agenda after an FID official wrote to DPC to request permission to start legal action. If DPC approves the initiation of the legal cases, the only remaining matters will be to decide which individuals to prosecute and to secure the approval of the government. DPC has arrived at this position following more than one year of consultation among various groups about how to proceed.
The consultation stems from regulatory actions initiated by the Drug Regulatory Authority of Pakistan (DRAP). At the request of DRAP’s Division of Costing & Pricing, FID seized batches of eight products from four manufacturers. Inspectors impounded hundreds of thousands of packs of Merck Serono’s diabetes medicine Glucophage and antispasmodic Buscopan. At Sandoz, the generic unit of Novartis, FID seized batches of two different formulations of the antituberculosis drug pyrazinamide. Wilson’s Pharmaceuticals and Scotmann Pharmaceutical also both had two of their products seized by FID.
Wilson’s and Scotmann, both of which are headquartered in Pakistan, have filed suits in civil courts, actions that have prohibited discussion of their cases elsewhere. These restrictions do not apply to Merck Serono and Sandoz, which could find themselves subject to legal action if DPC signs off on the proposal at its meeting.
The meeting will consider demands by drugmakers to raise the prices of hundreds of products under the hardship mechanism of the drug pricing legislation, which permits increases under certain circumstances. DPC has rejected many requests in the past.