Posted 06 December 2016
By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
DTAB Proposes Stipulations to Indian Plan for Permanent Licenses
The Indian Drugs Technical Advisory Board (DTAB) has given its conditional support to end the need to renew licenses to make, sell and test drugs. DTAB is broadly in favor of the idea, but has suggested stipulations that are more burdensome than those proposed by the Drug Controller General of India (DCGI) in October.
At a meeting last month, DTAB said it agreed licenses to make and sell drugs should remain valid forever, provided regulators and companies meet certain conditions. The most intrusive stipulation for manufacturers — and burdensome for regulators — relates to the frequency with which facilities must be inspected. DCGI Dr. GN Singh originally suggested inspectors must assess a site’s compliance with regulations at least once every 10 years. DTAB, in contrast, wants inspectors to assess each site at least once a year, unless a risk evaluation justifies a less frequent schedule.
Under the conditions proposed by DTAB, inspectors would share their observations with the licensee immediately after the conclusion of their visit. DTAB also wants inspectors to upload observation reports to a state or national website so the public can see the findings. The stipulation is part of a broader proposal to keep the public informed of the status of facilities. Another of the conditions proposed by DTAB would make state and central drug regulators maintain and share online data about which facilities inspectors have rated as satisfactory.
The conditions proposed by DTAB would dilute the impact of the original proposal, which DCGI Singh put forward as part of a wave of initiatives designed to make India a better place for drug developers and manufacturers to do business. Singh opened the proposal up for comment in October, before seeking the advice of the senior officials who make up DTAB last month. The proposals put forward by DTAB are not binding, but under the Drugs and Cosmetics Act, 1940, the board plays a central role in shaping technical aspects of government policy.
DTAB considered the never-ending license proposal alongside eight other topics. The agenda included a discussion of one of the other changes put forward by Singh, namely the alignment of India’s Schedule M with World Health Organization (WHO) good manufacturing practices (GMPs). DTAB agreed to the proposal unconditionally, moving India a step closer to the day its standards are up to WHO GMPs.
TGA Sets out Regulatory Agenda for 2016-17
The Therapeutic Goods Administration (TGA) of Australia has released its business plan for 2016-17. TGA uses the document to set out its regulatory agenda for the coming year, a period in which it will work through recommendations made in a review of oversight of drugs and devices in Australia.
With the review’s recommendations providing a blueprint for TGA activities, many of the changes TGA plans to deliver are well known. For example, the business plan lists the creation of priority review and provisional approval pathways as tasks awaiting the attention of TGA. The need for such pathways was raised in the review of the regulatory landscape. TGA’s focus on identifying and sharing workloads with comparable foreign regulators is also in keeping with recommendations made by the reviewers.
Other planned activities have been less widely publicized. The biologics team at TGA is planning to deliver guidance on sponsors’ post-market obligations and assess whether changes to the regulatory framework for autologous cells are needed. Other units are working to create a portal through which companies can file applications for new ingredients, finalize the implementation of a risk-based laboratory testing program to monitor compliance and complete adoption of a strategy for managing drug shortages.
TGA also used the business plan to provide an update on its collaboration with regulatory officials in New Zealand. The agency collaborated with its equivalent in New Zealand through the Australia New Zealand Therapeutics Products Agency (ANZTPA) until that initiative fell apart in 2014. While ANZTPA is now over, trans-Tasman collaboration continues. TGA picked out pharmacovigilance information sharing and mutual recognition of GMP inspection reports as areas in which it plans to cooperate with the New Zealand Medicines and Medical Devices Safety Authority over the coming year.
CFDA Commits to ‘Double Random’ Inspections to Improve Oversight
The China Food and Drug Administration (CFDA) has committed to adopting a “double random” approach to inspections to improve oversight. The concept involves randomly selecting both the organization or process being inspected and the officials who will carry out the work.
Officials in the Chinese government see the approach limiting opportunities for corruption, leading to the National Energy Administration, the General Administration of Quality Supervision, Inspection and Quarantine and other departments adopting the model. CFDA has now added its name to the list of Chinese agencies to begin moving toward the double random approach.
The regulator wants departments at all levels of its organization to adopt the model. Work is already underway to build random checks into regulatory processes at CFDA. Such checks could act as a deterrent to fraudulent and corrupt activities by making companies and officials fear CFDA will find out about their wrongdoing.
CFDA signaled its intention to transition to the way of working in a notice about improving oversight of food and drug safety. Overarching goals for the initiative include improvements to the efficiency of regulatory oversight in China and standardization of enforcement activities.
CFDA Circular (Chinese)
CDSCO Seeks Feedback on Effect of e-Governance Project
The Central Drugs Standard Control Organization (CDSCO) is seeking feedback on the effects of its e-governance initiative and other attempts to lessen regulatory burdens. CDSCO embarked on the project to move processes online to make the time it takes to handle regulatory requests shorter and more predictable, and now wants to know if it has achieved these goals.
To deliver such insights, CDSCO is asking organizations to tell it the extent to which the transition of various regulatory interactions to online platforms and other business-friendly schemes have saved them time and other resources.
CDSCO is keen to hear about the effect of:
- The Sugam online application system
- Risk-based inspections
- DCGI’s complaint-handling cell
- Legislative changes
- CDSCO staff training initiatives
By gathering feedback on the effect of the initiatives on the industry, CDSCO is hoping to build a picture of whether it has achieved its goals to date and identify areas in which it can improve. The regulator is accepting feedback for three weeks.
CDSCO has asked applicants who have filed for approval of global clinical trials but are yet to receive no objection certificates to re-submit their applications through its Sugam online portal. The request comes a little more than one month after CDSCO started using Sugam for global trials. CDSCO Letter
TGA has published guidance to help manufacturers of medical devices and in-vitro diagnostics to make changes to entries in the Australian Register of Therapeutic Goods (ARTG). Companies need to make such revisions when information needs updating or the purpose of a device has changed. The guide walks companies through the fees and forms that are needed to make changes. TGA Guide
St. Jude Medical has issued a hazard alert for Nanostim leadless cardiac pacemakers after discussing a malfunction with TGA. TGA Statement