Asia Regulatory Roundup: Australia Looks at New Regulatory Pathways (30 June 2015)

Regulatory NewsRegulatory News | 30 June 2015 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Australian Regulatory Review Urges Creation of New Drug Approval Pathways

An independent, government-commissioned review into regulations in Australia has recommended creating new drug approval pathways. The proposal would give developers of new chemical entities (NCEs) three pathways, including one in which the filing to Australia’s Therapeutic Goods Administration (TGA) would be based on an unredacted evaluation report from a foreign regulator.

If adopted, the recommendations would mark a leap forward in the push to have TGA rely more on the work of its regulatory peers. The specific details of the proposed pathways for NCEs, biosimilars and generics and medical devices vary, but each has two common ideas. In each case, companies can either submit a new application to TGA or repurpose an approval from an overseas regulator to support their case.

The recommendations include stipulations to lessen worries about the consequences of TGA upping its acceptance of the assessments of foreign regulators. Only national regulators that meet a set of transparent criteria will be accepted as comparable authorities. The criteria include the similarity of the demographic to Australia and the adoption of International Conference on Harmonization (ICH) guidelines. TGA will assess evaluation reports from such regulators before making its own decision.

Developers of NCEs and medical devices will also have a third approval pathway beyond the wholly new and foreign regulator-supported models. This third pathway will allow for the speedy approval of products in certain circumstances. The proposal, along with several others, was welcomed by trade group Medicines Australia. Whether any of the proposed plans come to fruition will depend on the government, which is currently reviewing the panel’s recommendations.

Expert Panel Recommendations, Press Release

CDSCO to Become CDA as India Looks to Match US Regulatory Standards

The Indian health ministry has proposed revamping the Central Drugs Standard Control Organization (CDSCO) to bring it up to the standard of the United States Food and Drug Administration (FDA). Yet another hiring push, a rebranding and the transfer of oversight to the Ministry of Health have been planned as India continues its struggle to establish a regulatory system fit for its burgeoning industry.

Bloomberg TV broke news of the planned revamp. The plan is at an early stage — the health ministry just shared a draft note with other wings of the government — but officials know what they want to change. If the plan comes into force, CDSCO will be rebranded as the Central Drugs Administration (CDA), a symbolic change that is indicative of the desire to close the gap between regulatory standards in India and the US.

To achieve this goal in practice and not just in name, the health ministry is planning to triple staffing at the regulator, bringing its headcount up to 1,800 by 2025. The hiring spree is the latest in a long line of similar proposals. In 2013, a CDSCO official proposed a ten-fold jump in drug inspection staff. A year later, the government committed to growing the ranks of inspectors from 500 to 1,000 within three years. Enacting such plans has proven to be tougher than making them, though.

Money is part of the issue. The health ministry is seeking a budget of Rs 1,729 crore ($270 million) for the revamp, a sum that will need to be used well if officials are to achieve their goals. The scale of the task was laid out this week by a Department of Pharmaceuticals task force, which found that in 2013-14 CDSCO had 340 sanctioned posts. FDA had 13,000 posts. The task force also recommended the setting up of regulatory cells in National Institutes of Pharmaceutical Education and Research.

Bloomberg TV, PharmaBiz

DTAB Proposes Aligning Indian Medical Device GMPs With ISO

The Drug Technical Advisory Board (DTAB) has joined the chorus of voices calling for India to bring its good manufacturing practices (GMPs) for medical devices in line with International Organization for Standardization (ISO) guidance, PharmaBiz reports.

Medical device manufacturers have led the calls for India to harmonize with ISO 13485, a document published in 2003 that outlines how to implement a quality management system at a medical device facility. Now, six months after CDSCO released draft guidelines that called for manufacturers to set up systems that comply with ISO 13485, DTAB has recommended an alignment of regulations to the government.

DTAB’s recommendations can be ignored by higher powers, but such a decision would go against the wishes of many groups, including the local medical device industry. The Association of Indian Medical Device Industry (AIMED) has led the push and thinks it is now on the cusp of achieving some of its goals. AIMED Forum Coordinator Rajiv Nath said the government is now ready to remove the medical device sector from Schedule M, a change for which the trade group has lobbied intensively.


Other News:

China’s three top telecommunications businesses, more than 50 Internet-based companies and five courier services have signed a pact against illegal drug activity. The signing of the pact followed the release of a protocol by nine government agencies and the Internet Society of China that advocated a zero tolerance approach to illegal online activities involving drugs. Xinhuai

The Indian Pharmaceutical Association (IPA) is pushing for regulatory affairs science to be taught and researched more in higher education. IPA is talking to the government and Drugs Controller General of India (DCGI) about the need for such academic-level regulatory affairs science, which it thinks will drive an increase in the pool of skilled regulatory professionals in India. PharmaBiz

TGA has reminded the medical device industry that the transition period for commercial in-vitro diagnostics (IVDs) ended on June 30. The event means IVD medical devices must now be submitted for inclusion in the Australian Register of Therapeutic Goods and comply with the relevant regulatory framework. TGA Notice

An expert committee set up by the Indian government has met to discuss how to implement track and trace requirements. The meeting looked at the ability of small businesses to cope with the cost of adopting track and trace, the capabilities of service providers and the availability of technology. Similar meetings are scheduled to take place in Ahmedabad, Goa and Hyderabad. PharmaBiz

Dr. S. Satheesh Kumar, the high-profile former drugs controller of Kerala, has called for the creation of an Office of Drug Safety in each Indian state. The proposed offices would allow regulators to split up their licensing and safety activities, increasing their focus on what Kumar sees as a neglected area of oversight. Kumar called on CDSCO to consider the proposal. PharmaBiz

Pakistani newspaper The Nation has published an editorial lambasting the drug pricing situation in the country. The piece criticizes the Drug Regulatory Authority of Pakistan (DRAP) for allowing a company to sell a cancer drug for three times the import cost and the government for failing to adopt a system to assess the costs of prescription drugs. The Nation

Drug inspectors at CDSCO West Zone are set to start receiving training on the online Underwriters Laboratories’ system developed for FDA officials. Around 15 officers will receive training on the platform, the usefulness of which has been assessed by state and national regulators in India over the past year. CDSCO West Zone includes a handful of states. PharmaBiz


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