Clinical Therapeutics May 2017 Volume 39, Issue 5, p873-1076

Clinical Therapeutics
May 2017 Volume 39, Issue 5, p873-1076
http://www.clinicaltherapeutics.com/issue/S0149-2918(17)X0004-0

Commentary
Vitamin D Status and the Host Resistance to Infections: What It Is Currently (Not) Understood
Pierre Olivier Lang, Richard Aspinall
p930–945
Published online: April 27, 2017

Reviews
The New Drug Conditional Approval Process in China: Challenges and Opportunities
Xuefang Yao, Jinxi Ding, Yingfang Liu, Penghui Li
p1040–1051
Published online: April 18, 2017
Abstract
Purpose
Our aim was to characterize the newly established new drug conditional approval process in China and discuss the challenges and opportunities with respect to new drug research and development and registration.
Methods
We examined the new approval program through literature review, law analysis, and data analysis. Data were derived from published materials, such as journal articles, government publications, press releases, and news articles, along with statistical data from INSIGHT-China Pharma Databases, the China Food and Drug Administration website, the Center for Drug Evaluation website, the US Food and Drug Administration website, and search results published by Google.
Findings
Currently, there is a large backlog of New Drug Applications in China, mainly because of the prolonged review time at the China Food and Drug Administration, resulting in a lag in drug approvals. In 2015, the Chinese government implemented the drug review and registration system reform and tackled this issue through various approaches, such as setting up a drug review fee system, adjusting the drug registration classification, and establishing innovative review pathways, including the conditional approval process.
Implications
In Europe and the United States, programs comparable to the conditional approval program in China have been well developed. The conditional approval program recently established in China is an expedited new drug approval process that is expected to affect new drug development at home and abroad and profoundly influence the public health and the pharmaceutical industry in China. Like any program in its initial stage, the conditional approval program is facing several challenges, including setting up a robust system, formatting new drug clinical research requirements, and improving the regulatory agency’s function for drug review and approval. The program is expected to evolve and improve as part of the government mandate of the drug registration system reform.

Commentary
Incorporating Site-less Clinical Trials Into Drug Development: A Framework for Action
Irl B. Hirsch, Joe Martinez, E. Ray Dorsey, Gerald Finken, Alexander Fleming, Chris Gropp, Philip Home, Daniel I. Kaufer, Spyros Papapetropoulos
p1064–1076
Published online: April 14, 2017
Open Access