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China Moves Rapidly Toward International Harmonization

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By Shannon Ellis
Contributing Writer

SHANGHAI – China is working to more closely align its legislative and regulatory system for drug registrations with international norms.

The CFDA is considering regulatory amendments around investigational new drug (IND) submissions and the National People's Congress (NPC) has included a new drug law in its legislative agenda, although it could take as long as a decade for the new law to emerge.

"(The) system is changing so fast every time you look away you come back lost," said Chloe Liu, managing partner at Modular R&D LLC, of Shanghai, a consultant and clinical project management firm. "A lot is happening already. The CFDA is improving all the time, but the industry is moving very fast. Many of the regulatory improvements the CFDA had committed to have happened this year."

The CFDA, with newly minted ministry-level status since March, oversees a three-tier legal framework that guides drug development, manufacturing and sales. The current system was developed originally to cater to generics manufacturing and is now hard-pressed to meet the demands of increasingly innovative drugs coming into the market.

The overarching legislation is the Drug Administration Law that is implemented through a series of regulations and guidelines. Drug registration regulations are used for IND approvals and outline the new drug application (NDA) process.

A 1985 version of the Drug Administration Law included two sets of drug registration regulations. The law was scrapped and a new one came into effect in 2001, and the implementation regulations have been updated three times since.

A new set of opinions on implementation, which outline priorities for regulators, was adopted in March.

"Opinions are official hints about how a certain regulation might likely be changed or interpreted going forward. What this creates is a de facto period of testing the waters for the public's mood," said Damjan Denoble, a partner at Rubicon Strategy Group, of Seattle, a consultancy specializing in emerging markets.

The constant revisions to the legislative and regulatory environment are a direct side effect of the regulators' efforts to catch up with global standards and address industry concerns, one of which is the sheer length of time it takes to register new drugs in China.

A 2009 amendment to the regulations, the New Drug Registration Special Review Policy, created a green channel for the fast registration of innovative drugs.

The new set of opinions issued in March created fast tracks for drugs for rare diseases, pediatric drugs and first generics. Still, it can take years to get a new drug into the Chinese market.

The China Association of Enterprises with Foreign Investment's R&D-based Pharmaceutical Association Committee (RDPAC) that represents 39 foreign pharmaceutical companies, declined to comment, saying it was inappropriate to comment while changes are under consideration but its website calls on the government to address this constraint that has "delayed innovative medicines four to five years and weakened China's competitiveness in accessing global research resources."

There are crucial differences between the regulatory systems in the U.S. or the EU and the system in China. The March opinions aim to close some of the gaps, including disseminating the risk and responsibility for new drugs.

The new regulations suggested that the government now wants to streamline the system and spread clinical trial responsibility among sponsors, the institutional review board, principal investigators and the public.

"The redistribution of risks and responsibilities among all stakeholders, away from the regulatory agency alone, represents a fundamental shift in regulatory philosophy, which may change how the CFDA reviews IND applications," Liu explained.

Steep pharmacology requirements and large requests for manufacturing information that were a part of IND applications are lightened in the new regulations. For example, pharmacological data can be revealed as they present themselves in the study rather than given up front.

The regulatory changes may be just the tip of the iceberg in the current legislative evolution of China's pharmaceutical industry. The NPC has included a new drug law in its legislative plan, although it is uncertain when this law will be drafted or enacted.

"Maybe five or 10 years, or maybe sooner," Liu noted. "There have been a lot of changes in the last six or seven years. It seems natural to see the next version of the drug administration law to reflect the accumulated changes. As we saw with the Social Security law, it was put into the NPC legislative plan in 2004, and was passed in 2010."