Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Releases Medical Device Adverse Event Reporting Form for Consultation The Indian Pharmacopoeia Commission (IPC) has released a medical device adverse event reporting form for consultation. IPC has drafted the template as part of the drive in India to establish a materiovigilance program to monitor the safety of medical devices. Once the form is finalized, filers o...

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) has elected Paul Hargreaves of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) as its new chairman for 2016 and 2017. Hargreaves, elected at a meeting in Indonesia last month, will be the fourth PIC/S chairman from the UK and he will follow the departure of Joey Gouws, acting head of South Africa’s Medicines Control Council, who was the first PIC/S chairperson from Africa.   Following the succe...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. FIA Remands 4 Senior Pakistani Officials in Fraudulent Drug Approval Case The Federal Investigation Agency (FIA) has remanded four senior officials at the Drug Regulatory Authority of Pakistan (DRAP). FIA took the action after investigating the alleged issuance of a fake drug registration letter for a treatment for premature ejaculation. DRAP’s deputy director general o...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Trial Data Quality Drive Leads to Rejection of Applications China Food and Drug Administration (CFDA) has rejected 11 applications from eight manufacturers as part of its clampdown on the quality of clinical trial data included in submissions. The rejections come four months after CFDA began a drive to root out applications with incomplete or subpar data. None of the...

AHWP Releases Guidance on Harmonizing Medical Device Submissions in Asia The Asian Harmonization Working Party (AHWP) has posted guidance on the preparation of a common submission dossier template for the region. AHWP views the guidance as a step toward eliminating the need for medical device manufacturers to create individually formatted dossiers for submission in China, India and its other member countries. As it stands, companies pursuing the approval of medical de...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Proposes Drug Approval Reforms to Encourage Innovation Senior Chinese officials are considering adopting legislation that would overhaul the drug evaluation and approval process in the country to encourage innovation by incentivizing research. As it stands, only manufacturers can apply for drug approvals in China. Officials are now considering whether this disincen...

This article discusses the contrasts between regulatory oversight of prescription drug advertising and non-advertising promotion in China. On 1 September 2015, several new requirements for the regulation of prescription drug advertising in China were implemented. (1) Recent legislative amendments to China’s Advertising Law , (2) the first significant revision of the statute since 1994, and corresponding proposed revisions to review standards and administrati...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Details New Approach to Medical Device GMP in Four Guidance Documents China Food and Drug Administration (CFDA) has moved to strengthen its oversight of medical device manufacturing. The new approach is detailed in four guidance documents covering medical device good manufacturing practices (GMPs), in which CFDA explains its approach to on-site inspections. CFDA...

Local clinical data are essential as supporting evidence for new drug applications (NDAs) in China. This article reviews the clinical development process of 148 new chemical entities (NCEs) and new therapeutic biological products approved in China from 2004 through mid-2014. It provides insights into critical regulatory considerations influencing the number of clinical trial patients and choice of development pathway needed to gain regulatory approval in China. Ch...

China is a mysterious and interesting country for the regulatory professional. It is of interest because of its enormous market potential (nearly a fifth of the world’s population lives in the People’s Republic of China) and the fact that China is one of the most important manufacturers of active pharmaceutical ingredients (APIs) for the EU and US. China exported 1.2 million tons of APIs to the EU and 0.6 million tons to the US in 2013. China is somewhat mysterious becau...

China's State Food and Drug Administration (SFDA) has announced that it is implementing a series of reforms designed to improve the drug review and approval process, "and to promote the healthy development of China's pharmaceutical industry."  Wang Lifeng, director of the SFDA's drug registration department, said the plan provides incentives for the research and development of innovative clinical drugs, adding that the approval process will be shortened for these...

The former Commissioner of the US Food and Drug Administration (FDA), Andrew von Eschenbach, has more than a few ideas about improvements that could be made to the agency he used to lead. In a series of articles, Eschenbach, now with The Manhattan Institute's Project FDA, has argued on behalf of making some potentially radical changes at the agency. In a February 2011 Wall Street Journal opinion piece , Eschenbach argued on behalf of a safety-based approval system in...