China's State Food and Drug Administration (SFDA) has set out a number of proposed changes to the drug registration process, providing encouragement for domestic innovation, and allowing the fast-track review of generic drugs in high clinical demand. Pricing and reimbursement incentives will also be offered for firms developing paediatric drugs.
IHS Global Insight perspective | |
Significance | Among the State Food and Drug Administration's proposals are rules that would establish a fast-track review process for drugs that are in high clinical need, a sorely needed reform as the Center for Drug Evaluation currently struggles under the weight of repeat applications for generics already available in the market. |
Implications | Innovative drugs that involve China-based intellectual property and/or government-directed research and development will be encouraged through fast-track reviews and regulatory approvals, while incentives within the tendering and pricing and reimbursement processes will be used to encourage greater development of drugs for paediatric use. |
Outlook | The reforms will be cheered by the industry, with further potentially significant changes on the horizon including greater involvement of local authorities in drug registrations. |
China's State Food and Drug Administration (SFDA) has issued a range of proposed reforms to the drug registration process in China addressing a number of inefficiencies. The proposals seek to introduce incentives to stimulate local innovation, research and development (R&D) into major diseases, and development of paediatric drugs; generics applications that satisfy areas of high unmet clinical need will be prioritised. The document was released on 8 December, with the window for public comments on the proposals closing yesterday (15 January). The contents of the press release are summarised below, and a link to the SFDA release (in Chinese) can be found here.
- Innovative drugs: The SFDA states it plans to use accelerated technical reviews and regulatory approvals to reward R&D which targets critical diseases and leads to the creation of Chinese intellectual property. Chinese government-sponsored R&D will be made high-priority during technical reviews. In terms of pre-clinical trials, the agency will encourage firms to ensure that pre-clinical studies are risk-based. The technical review of pre-clinical studies may be delegated to third parties. The agency will also consider including technical reviews alongside the ethics reviews, theoretically speeding up the process.
- Generics: High-priority generics will receive fast-track reviews, with a streamlined review process, including on-site inspections and product testing, separate from other generics. Generics offering little clinical value will be discouraged, with industry experts and non-government organisations to be consulted on development of an evaluation mechanism in this respect. Bioequivalence testing will be emphasised, alongside plans for a Chinese version of the United States' Orange Book.
- Clinical trials: Quality control over clinical trials will be tightened up, with steps to be taken to ensure effective and independent ethics committees. Greater transparency regarding clinical trials and public awareness of such trials will be promoted, such as establishing an English-language website on China-based trials.
- Paediatric drugs: Development of paediatric drugs will be encouraged through suitable tendering and pricing and reimbursement (P&R) incentives, while generic drugs suitable for paediatric use will be prioritised, with the potential for exclusivity periods.
- Drug registration rules: The SFDA plans to ensure that the Drug Registration Rules match international standards, and may begin to allow data from overseas clinical studies to be submitted during technical reviews and regulatory approvals. Communications between applicants and the Center of Drug Evaluation (CDE) are to be eased by an "online communication platform". The SFDA may also look to delegate more work, along the lines of a pilot scheme permitting Guangdong province's provincial FDA to carry out drug registrations that was initiated in November 2012.
Outlook and implications
The SFDA's reforms are only proposals at present, but they give an indication of the SFDA's short- and medium-term intentions. The emphasis on supporting local innovation and indigenous intellectual property does not necessarily exclude participation of foreign firms, with the importance of foreign firms having strong local connections and joint-venture relationships in China likely to be reinforced. Foreign firms would also stand to benefit directly if the SFDA eventually accepts overseas clinical trial data, with streamlined, more transparent review processes theoretically leading to faster drug development and approvals.
CDE clogged by generics
The proposals address some of the criticisms raised in a significant November 2012 report issued by the CDE looking at market access problems in China's generic market. The report – China Generics Development Report 2012: Market Access System – includes some astonishing revelations regarding the problems within China's drug registration system, and domestic generics industry as a whole. Chief among these is the problem of repeat applications for already approved drugs: in 2012, 58% of the 3,950 abbreviated new drug applications filed with the CDE were for products with over 20 other approved generic versions each. By way of extreme example of the inefficiencies the SFDA is trying to remedy, 20 Chinese companies sought approvals for generic versions of Merck & Co (US)'s Zocor (simvastatin) in 2012, but 116 approvals had already been granted for this drug in China. The current push for bioequivalence testing of China's generic drugs is likely to be central to the reforms process: requiring a drug be registered for bioequivalence testing in order to gain priority review would help to filter out Chinese firms issuing scatter-gun applications for generic approvals (see China: 14 December 2012: SFDA plans for bioequivalence testing of all generic drugs in China). The CDE's report (in Chinese) is available here.
The SFDA's proposals also signify the potential for much greater local authority involvement in the drug registration process – potentially expanding a pilot scheme initiated in Guangdong at the end of last year that saw drug approval responsibilities passed to provincial authorities (see China: 15 November 2012: China's SFDA trials provincial drug approvals in Guangdong province). Among the CDE's generics industry report were figures detailing the scale of the task facing the CDE, whose 17 reviewers dealt with more than 3,300 registrations during 2012. Drug companies will hope that the average generic drug registration timeline of four years (versus 2.5 in the United States) can be reduced. The overall scale of the task facing the SFDA is daunting, and it remains to be seen which reforms the government is able to achieve. The likelihood is that further consolidation within the domestic generics industry will be encouraged through stricter enforcement of the new good manufacturing practice standards.
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