Nanomaterial Submissions on the Rise
Based on recent FDA analysis, the number of submissions of drugs with nanomaterials has risen considerably over the last two decades. Of these, 65% are investigational new drugs, 17% are new drug applications and 18% are abbreviated new drug applications, with the largest class of products being liposomal formulations intended for cancer treatments. This analysis […]
CFDA Proposes Draft Lowering Barriers for Foreign Drug Manufacturers
In March 2017, the China Food and Drug Administration (CFDA) has released draft rules allowing Multinational Companies to include Chinese patients in the earliest possible stages of drug multi-regional clinical trials (MRCTs). These policies are meant to significantly reduce foreign drug registration timelines. The changes affect the following areas: 1) For imported chemical drugs and […]
Do We Really Need Regulatory Intelligence?
Regulatory intelligence (RI) has emerged as an essential tool for regulatory professionals, but do we really need it? The simple answer is, yes. Using RI will help you to become an effective regulatory professional by helping you to develop the most effective regulatory strategies, while at the same time helping to avoid costly and time-consuming […]
QMS for Virtual Companies
In today’s market, many biotech and medical device companies start off as a virtual or semi-virtual operation to keep fixed costs low. Virtual companies are run by a very small team, often one or two founders. With the rise of contract research organizations (CROs), contract manufacturing organizations (CMSs) and laboratories, most validation experiments right through […]
Reality check on 505(b)(2) NDA Approval Pathway
In 1984, the 505(b)(2) approval pathway was created to permit FDA approve new drug applications (NDAs) based on data from previously approved drugs and therefore streamline the development and approval process of new drug applications (NDAs). The 505(b)(2) pathway is very attractive to drug makers because it can shorten their development and cost timelines. Additionally, […]
China to offer Priority Review for Medical Devices from January 2017
China Food and Drug Administration (CFDA) recently announced that a ‘Priority Review and Approval Procedure for medical devices will come into force from January 1, 2017. The new pathway is based upon a set of draft rules released by the CFDA in August 2016 (Proposed Rules). As per these rules, certain medical devices are eligible […]
Special Approval Procedures for Innovative Medical Devices in China
Recently overhauled CFDA regulations place an emphasis on ‘fast-track’ approval channel for medical devices. In February 2014, the China Food and Drug Administration released Trial Procedures for the Special Examination of Innovative Medical Devices
Unique Device Identification: A Global Perspective
The Unique Device Identification (UDI) System is intended to provide a single, globally harmonized system for identification of medical devices. It is expected to improve patient safety, facilitate and improve the recall process, and create efficiencies within the medical system.
CFDA Publishes New List of Medical Devices Exempt from Clinical Trial Requirements
On September 30, 2016, the China Food and Drug Administration (CFDA) has published a new list of medical devices exempt from clinical trial requirements in for approval in the country. The new CFDA list includes 276 Class II devices and 92 Class III devices that became exempt from CFDA clinical trial requirements.
Medical Device Single Audit Program (MDSAP) in Japan
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.
A review of the changes in ISO 13485
On February 25, 2016, the International Organization for Standardization (ISO) published its revisions to ISO 13485 replacing the previous version from 2003. This is the global standard for medical device quality management systems (QMS). Over the next three years, ISO 13485:2003 and ISO 13485:2016 will coexist, allowing manufacturers, accreditation/certification bodies and regulators time to transition […]
‘’Overview of Authorization Procedures for Medicinal Products in Europe’’
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