On June 6, 2016, the CFDA released the 2015 Annual Report of Drug Inspection, an English-language report summarizing the findings of drug inspections carried out in China in 2015. The report is an effort to improve openness and accountability by the CFDA,... Read More
Throughout the past few years, the increased use of medical devices in China has helped many patients, but has also been the cause of serious injuries and deaths. In 2015, 184 people died and over 47,000 people experienced severe damage to their... Read More
The Association of Indian Medical Device Industry (AIMED) recently established a new program called the Indian Certification of Medical Devices Scheme (ICMED). Previously, there was no specific quality assurance system in India. This new scheme will standardize the level of quality for... Read More
In April 2016, the China Food and Drug Administration (CFDA) released a set of guidelines that regulatory officials should follow when inspecting medical device production facilities. The checklist provides inspectors with a comprehensive list of specific elements they should investigate including personnel,... Read More
A recent RAPS Focus review of US FDA inspection reports conducted in China and India reveals a number of data and quality deficiencies that are raising alarms in the US pharmaceutical community. According to the report, 42 Indian drug manufacturing sites are... Read More
In December 2015, India’s Ministry of Health agreed to institute new regulations that would separate the laws governing medical devices and pharmaceuticals. The proposed changes will also require new safety and efficacy tests to ensure that devices produced in India meet international... Read More
In July, India’s Ministry of Health and Family Welfare formally launched the Materiovigilance Program of India (MvPI). This plan will monitor the quality of medical devices in India and seek to improve patient health and safety. According to the Indian Pharmacopoeia Commission,... Read More
The China Food and Drug Administration (CFDA) issued more comprehensive guidelines for manufacturing three types of medical devices: sterile and implantable devices, and in-vitro diagnosis reagents. The guidelines for medical device manufacturing in China come into effect on October 1, 2015. The... Read More
The Drug Controller General of India (DCGI) has initiated strategies to strengthen regulatory oversight of India’s pharmaceutical industry. India expects to add about 200 more drug inspectors in the coming months to build up their drug regulatory capacity. Previously, oversight of India’s... Read More
In early July, the Chinese Food and Drug Administration (CFDA) announced that they will begin to conduct regular surprise inspections of pharmaceutical and medical device manufacturers starting on September 1, 2015. In addition to the regular inspections, a manufacturer may also be... Read More