China's Food and Drug Administration (CFDA) has rejected marketing approval applications from eight Chinese companies for 11 generics treatments on grounds of incorrect or inadequate clinical-trial data.
IHS Life Sciences perspective | |
Implications | The announcement follows a number of on-site inspections by the CFDA from 26–31 October. |
Outlook | Future marketing-approval rejections are expected to focus mainly on domestic manufacturers, rather than multinational firms with more experience of clinical-trial data preparation, but the CFDA's campaign may also result in increased red tape for multi-national pharma. |
China has rejected marketing approval applications from eight Chinese companies for 11 treatments, on grounds of incorrect or inadequate clinical-trial data, according to the China Food and Drug Administration (CFDA); read the Chinese-language statement here. The 11 medications – all generics treatments – are indicated for a range of diseases, including cardiovascular, schizophrenia, pain, infections, and other indications.
Drug marketing approvals rejected by CFDA, November 2015 | |
Drug | Sponsor company |
Clozapine orally disintegrating tablets | Hainan Pharmaceuticals (China) |
Candesartan cilexetil tablets | Zhejiang Huahai Pharmaceutical (China) |
Azithromycin capsules & amlodipine besylate tablets | Hebei Pharmaceutical (China) |
Nifedipine GITS | Qingdao Bai Yang Pharmaceutical (China) |
Clopidogrel bisulfate tablets | Zhejiang Angli Kang Pharmaceutical (China) |
Racecadotril dry mix suspending agents | Hainan Kang Chi Pharmaceutical (China) |
Isosorbide mononitrate sustained release tablets | Guangdong Pharmaceutical (China) |
Ibuprofen suspension drops & ibuprofen suspension | Shandong Da Yinhai (China) |
Source: CFDA | |
The announcement follows a number of on-site inspections by the CFDA from 26–31 October. In July, the CFDA announced it would begin conducting surprise inspections from 1 September, and called for manufacturers to self-audit their clinical trial data (see China: 9 July 2015: China's FDA to conduct surprise inspections on drug makers and medical device manufacturers; China: 28 July 2015: China's FDA launches campaign forcing pharmaceutical companies to self-audit clinical trial data).
China has stepped up its campaign to improve the quality of domestic pharmaceutical manufacturing, spurred in part by warning letters from the US FDA (see China: 7 January 2015: China's FDA pledges to strengthen "grim" drug safety control following US warning letter).
Outlook and implications
The marketing-approval rejections reflect the CFDA's campaign to control sub-standard clinical trial data. The results are on a par with those of the CFDA's self-auditing campaign in late July, which resulted in the 10 applicants (all local firms) having their applications rejected (see China: 2 September 2015: China releases results of pharmaceutical clinical trial self-auditing campaign). However, given the scale of the CFDA's campaign, and the sheer number of generics manufacturers in China, it is somewhat surprising that so few applications have been rejected.
Looking ahead, any future rejections by the CFDA of marketing-approval applications is expected to be handed mainly to domestic manufacturers, rather than multi-national firms with more experience of clinical-trial data preparation. However, the increased intensity of CFDA oversight and inspection may result in additional red tape for multi-national pharma, with administrative requirements expected to increase as China brings its drug-approval process in line with those in the United States and Europe.