Drug regulatory body in any country or market is responsible for maintaining the safety, efficacy, and quality of drugs manufactured, sold, and marketed in their relevant area by performing different activities. One of them is updating their existing regulations and defining new ones.
The regulatory bodies continuously update their regulations due to different factors such as new research, feedback from industry experts, and market complaints. These regulations become part of their law, and the member pharma manufacturers must comply.
This article will explore new regulations in countries like the United States, Europe, Japan, and Australia.
United States FDA
United States FDA is responsible for maintaining the drug regulations in the United States. Some new regulations by the FDA are briefed below
Submitting patient reported outcome data in Cancer clinical trials
It guides meeting patient-reported outcome data collected in Cancer clinical trials related to medical products for market application.
Remote interactive evaluation of drug manufacturing and bio research monitoring facilities
This guidance provides details about conducting remote voluntary evaluations for drug manufacturing packing processing compounding or holds under FDA bioresearch monitoring program
Communication from firms to health care providers regarding scientific information on unapproved use of approved / cleared medical products questions and answers
This guidance will provide MDS perspective regarding questions related to certain communications by pharma manufacturers to healthcare providers on unapproved uses of approved cleared medical products
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol;
This guidance is intended to alert Pharmaceutical manufacturers specializing in drug compounding with ethanol (ethyl alcohol or ethanol or isopropyl alcohol) about methanol contamination.
Diabetic Foot Infections: Developing Drugs for Treatments
This guidance is intended to help sponsors in the clinical development of drugs to treat diabetic foot infections
Stimulant Use Disorders: Developing Drugs for Treatment;
The purpose of this guidance is to assist sponsors of clinical development in the treatment of stimulant use disorders.
Stimulant Use Disorders: Developing Drugs for Treatment;
This guidance assists in labeling dose bands which is based on the previously approved drug product (based on weight or body surface area)
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
This is the guidance related to the final meeting between the FDA and the applicants ( or sponsors) when developing a new drug product regulated by CDER and CBER. However, this guidance does not cover abbreviated new drug applications, applications for biosimilar biological products, or medical devices.
Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies
This guidance provides recommendations for clinical trial sponsors in cases where clinical trials can be disrupted due to emergencies or disasters ( such as hurricanes, earthquakes, military conflicts, infectious diseases, or bioterrorist attacks)
Annual Status Report Information and Other Submissions for Post marketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989;
This guidance intends to facilitate drug and biological submissions with complete and accurate information about post market requirements and commitments.
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products
This guidance intends to provide recommendations to institutional review boards - IRB and clinical investigators to consider specific key factors and procedures when reviewing individual patient-expanded access submissions.
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Inve...
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