Therapy through video games and their regulation

090702-N-1783P-003The use of video games in areas such as science, medicine and healthcare is not a new concept. In fact clinical trials have been looking at using games as a new form of rehabilitation for at least 15 years. In the past few years however, the use of video games as therapies has increased due to the desire of medical professionals to find newer, innovative and cost-effective methods of treatment.

Biosimilars – A naming and labelling challenge

Blog 33 - Biosimilars-1 One of the challenges posed to regulators will be the naming requirements for biosimilars. In order for physicians to select the most appropriate biosimilar medicinal product and also for pharmacovigilance purposes, the question has been asked as to what proprietary and/or non-proprietary name should be permitted for use on biosimilar products.

An Introduction to CMC Regulatory Compliance

The importance of a robust change-control system

Intro to CMC Regulatory ComplianceChemistry, Manufacturing and the Controls (CMC) of a medicinal product is the body of information that defines not only the manufacturing process itself but also the quality control release testing, specifications and stability of the product together with the manufacturing facility and all of its support utilities, including their design, qualification, operation and maintenance.

The Gulf Central Committee for Drug Registration (GCC-DR)

GCC-DR structure, registration process and points to consider when choosing this route to registration

Gulf Central Committee for Drug Registration
The Gulf Central Committee for Drug Registration (GCC-DR) was formed in May 1999 with six Middle Eastern States – Saudi Arabia, Kuwait, Qatar, Bahrain, Oman and the United Arab Emirates; and in 2003 Yemen became the seventh member of the GCC-DR.  The aim of the GCC-DR is to work together to review/approve pharmaceutical companies and their drugs by means of a centralised registration procedure in order to provide the seven member states with safe and effective medicines with a reasonable price.  Included in the structure of the GCC-DR is a permanent Secretariat with responsibilities including the receiving/reviewing of registration files for completeness, 2 members nominated from each State regulatory authority (collectively called the “Steering committee”) with duties including company/product registration and guideline approval, a general director, an executive board, and at the highest level the Council of Ministers of Health (CMH).  The CMH consists of health ministers from each of the seven member States and overseas approval of all guidelines and policies adopted by the Steering committee.

The FDA’s Regulatory Approach to Ebola Therapeutics

Ebola PicIn August 2014, an Emergency Committee meeting, under the International Health Regulations (2005) regarding the ‘2014 Ebola Virus Disease (EVD) outbreak in West Africa’ was held, with WHO later releasing a statement saying that this epidemic had reached the status of Public Health Emergency of International Concern.