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Regulatory News | 29 August 2017 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The China Food and Drug Administration (CFDA) has detailed the data management standards it expects companies to follow when researching, developing, making, distributing and monitoring the use of medicines. The rules hold senior management responsible for the reliability of data.
CFDA set out its expectations in a draft document that calls for companies to establish processes, teams and working cultures that ensure data is traceable and reliable. One part of the challenge of setting up such a system is technical. Yet, the subterfuge encountered by foreign regulators when trying to inspect sites in China shows the culture of some companies is also an impediment to the establishment of reliable, transparent data management systems.
Recognizing this, CFDA devotes a section of its guidance to the softer, less-technical characteristics of companies that effectively manage their data. The text tasks senior managers with establishing a corporate culture that prioritizes quality and allocating enough resources to enact their data management programs. These managers must ensure systems to safeguard data reliability are insulated from other business factors, minimizing the risk pressures will lead teams to cut corners.
The agency expects senior management to periodically review data management activities. If the audit uncovers violations of data management requirements, the company must perform a comprehensive investigation of the situation and take corrective and preventative actions. Particular risk-control measures apply to violations that may affect product quality or harm patients.
CFDA is incentivizing managers to prioritize data quality by making them ultimately responsible for any failings. With separate regulatory and legal changes and clarifications opening the door to the punishment of individuals involved in data fraud, China has the means to back up its threats.
Other sections of the text cover technical considerations familiar to people involved with data management in all organizations and regulatory regions. The guidance prohibits the use of shared or generic login details for data management systems. CFDA’s document also permits the use of electronic signatures, provided they are validated, tasks companies with ensuring their system creates an audit trail and mandates the regular backing up of data.
CFDA is accepting feedback on the draft until 1 October.
CFDA Notice (Chinese)
Roche has become the first company to win priority review status for a medicine in Australia. The Therapeutic Goods Administration (TGA) awarded the status to anaplastic lymphoma kinase (ALK) inhibitor alectinib, positioning Roche to benefit from an expedited review when it files for approval in patients with non-small cell lung cancer (NSCLC).
TGA expects to take about five months to process applications for medicines with priority review status, three months less than the timeline for standard submissions. The agency put the program in place to allow Australians with major unmet medical needs to access effective drugs sooner, much like established pathways in Canada, the European Union and United States do for patients in those regions.
The pathway went live at the start of July, bringing the end to the regulatory reform process that began with the expert panel review in 2015. TGA began accepting notifications of interest in the pathway — which it wants sponsors to file at least one month before their applications — shortly before the program formally started. That resulted in a timeline TGA foresaw leading to the award of the first priority designations in August.
TGA’s acceptance of Roche’s alectinib into the program means the scheme is running to schedule so far. Roche now has until 21 February 2018 to file for approval if it is to receive an accelerated review. The time limit is a result of TGA’s decision to have priority review designations lapse after six months. TGA envisions sponsors typically seeking a priority review designation 10 to 12 weeks before filing for approval, much like happens in the EU under the accelerated assessment scheme.
The Drug Controller General of India (DCGI) has asked state regulators to enforce rules about the submission of stability data. DCGI Dr. GN Singh wants local officials to remind manufacturers to file stability data when they seek permission to produce off-patent and proprietary medicines.
Legislation covering the provision of licenses to make and distribute generic and innovative drugs in India states applicants must share data showing their products are stable under recommended storage conditions. Singh’s letter makes no mention of whether Indian licensing authorities have been failing to enforce this requirement. Yet, the fact the DCGI felt the need to send the letter suggests some manufacturers have received licenses without providing stability data.
Singh used the letter to try to stop this happening and remind his colleagues of the importance of stability data. As Singh puts it, “Stability of drug is of paramount importance to ensure quality, safety and efficacy of the drug throughout its shelf life.”
The publication of Singh’s letter comes about five months after DG Shah, the secretary general of the Indian Pharmaceutical Alliance, said most drugs sold in India have never proved their stability. Shah preceded his claim by stating filings for approval of generics made four years after the first copycat product comes to market do not need to provide stability data. The lobbyist thinks 85% of products are introduced four years after the first generic version of a drug comes to market.
Singh’s letter makes no mention of the four-year rule. The Drugs and Cosmetics Rules, 1945 law he cites states: “The applicant shall furnish to the Licensing Authority, if required to do so, data on the stability of drugs which are likely to deteriorate for fixing the date of expiry which shall be printed on the labels of such drugs on the basis of the data so furnished.”
China has released documents detailing its position on the reporting and investigating of crimes related to medicines. The documents explain the division of responsibilities between organs of the Chinese state and set out a model for encouraging the public to report illegal activities.
One of the documents establishes guidelines for the rewarding of whistleblowers. This includes how to calculate how much the whistleblower receives — sums of up to RMB 500,000 ($76,000) are mentioned — and how to allocate the reward in the event two people come forward with the same information.
The document also covers the need for regulators to report criminal wrongdoing — including the making of knowingly false accusations by “whistleblowers” — to the judicial system. This is where the second document comes in.
In the investigation text, Chinese officials set out who is responsible for what and propose ways to improve the system. The document also covers the process for handing out administrative penalties.
Investigation Text, Reporting Text (both Chinese)
TGA has stopped allowing the sale of unapproved carbimazole tablets intended for the United Kingdom market. The agency allowed the import of the drug from Amdipharm Mercury to enable patients to access the hyperthyroidism medicine while the local supplier dealt with a production issue. That issue is now resolved, resulting in the registered product returning to normal supply chains.
Tags: Asia Regulatory Roundup, Roche, DCGI