Top Clinical Research Regulatory News in 2016
Below mentioned are some of the interesting and worth reading news in 2016 related to Clinical Research Regulatory
ICH Wants to Rebuild GCP Guidelines and also Added New Members: International Council for Harmonisation (ICH) Members agreed upon various moves that would rebuild the ICH’s good clinical practice (GCP) guidelines while in a meeting in Japan in November 2016.
Teva’s Reformulated Levothyroxine Gets Approval from UK’s Commission on Human Medicines: UK drug advisory body Commission on Human Medicines (CHM) has permitted Teva to reintroduce levothyroxine tablets in the United Kingdom market.
ICH Proposes Two New Guidelines: The International Council for Harmonisation (ICH) has introduced two new guidelines, with one (M9) providing recommendations to support the bio-pharmaceutics classification of medicinal products, while the other (M10) is applicable to the validation of bio-analytical methods and study sample analyses in nonclinical and clinical studies.
US FDA Discloses Guidance on SaMD for Consultation: US regulatory authority Food and Drug Administration (FDA) on 13th October 2016, opened a public a consultation on a harmonized guidance on the clinical evaluation of software as a medical device (SaMD) formulated by the International Medical Device Regulators Forum (IMDRF).
FDA Final Guidance on Microbial Vectors Used for Gene Therapy: The US FDA’s Center for Biologics Evaluation and Research, recently released final guidance for the investigational new drug (IND) submissions for microbial vectors used for gene therapies (MVGTs) in early phase clinical studies.
Australia Steps Closer to Setting up Expedited Review: Australia has moved its expedited review program one step closer to fruition by approving the suggestions of an expert panel, which called for the formation of an expedited review process and a choice to leverage international approvals when trying to bring a medicine to market in Australia.
Carb-X : Global Partnership Between U.S. and U.K. To Accelerate Novel Antibiotics Development : U.S. and U.K. health authorities have created a new partnership with funds of hundreds of millions of dollars to speed up the progression of new antibiotics and deal with the increasing issue of drug resistance.
WHO New Treatment Guidelines for Gonorrhea, Chlamydia, and Syphilis: The World Health Organization (WHO) on 30th Aug released new therapy guidelines for 3 sexually transmitted infections (STIs) (chlamydia, gonorrhea and syphilis), stating the updates respond to an “urgent need” in light of improving antimicrobial resistance.
EMA Revealed First Guidelines on PBPK Modelling: EU regulatory authority European Medicines Agency (EMA) on 29th July 2016 revealed its first-ever draft guideline targeted on the use of physiologically-based pharmacokinetic ( PBPK ) modellin.