Centralised Procedure: Organisation Management Service (OMS) now mandatory
The European Medicines Agency (EMA) regularly updates the "Questions & Answers (Q&A)" documents on its website relating to centralised marketing authorization procedures. Now, a catalogue with Q&As exclusively on the topic of "Organisation Management Service (OMS)" has been published on the EMA's eSubmission website.
EMA: Renewed Update of the Q&A Catalogue on "Centralised Procedures"
In October and November, the European Medicines Agency (EMA) once more published on its website the updated and revised version of the "Questions & Answers (Q&A)" document related to questions prior to and during the submission of a centralised procedure.
As international travel restrictions remain in place, the TGA's GMP remote inspection programme will continue. This means remote inspections remain the only available option for certification applications during the pandemic.
WHO publishes Guidance on Safe Production and Quality Control of Monoclonal Antibodies
In October, the WHO published a draft revision of the Guide for the Safe Production and Quality Control of Monoclonal Antibodies. It is a continuation of the guidance documents on this topic that have already existed since 1991.
HMPC adopts revised Quality Guidelines for Herbal Medicinal Products
EMA´s HMPC adopted the revised Guidelines on Quality and Specifications for herbal substances, herbal preparations and herbal medicinal products. Will a written GACP declaration for the herbal substance now become a requirement?
Compassionate Use: EMA supports Submission of Medicinal Product Information
To support voluntary submissions of medicinal product information for medicinal products supplied in the EU / EEA via parallel importation, or for emergency and compassionate use, new 'Legal basis' values will be made available in the "Article 57 database" (xEVMPD).
FDA issues Warning Letter for not complying with Clinical Trial Rules
The FDA issued a warning letter for not complying with regulations during the clinical investigation of a COVID-19- IMP. In particular, the sponsor failed to submit an investigational new drug application.
FDA´s Q&As regarding Clinical Trials during the COVID-19 Pandemic
The FDA updated the Q&As concerning the conduct of clinical trials during the COVID-19 pandemic. The document provides general considerations to assist sponsors in assuring the safety of trial participants & maintaining GCP compliance. Amongst others the guidance deals with electronic signatures, remote monitoring and re-monitoring after pandemic-related restrictions are lifted.
Medical use of cannabis has been legalized in Panama in October 2021. The new regulatory framework allows the use and controlled access to medical cannabis for therapeutic, medical, veterinary, scientific and research purposes.
Is Bracketing/Matrixing Acceptable During Generic Drug Development?
The Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) has published a Draft Guidance for Industry entitled "Questions and Answers on Quality Related Controlled Correspondence". The document contains, besides other topics, questions and answers related to bracketing and matrixing.
The FDA has published guidance to clarify how considerations about benefit-risk assessment are integrated into the agency´s pre- and postmarket decisions for marketing applications. Read more about FDA´s draft guidance on Benefit-Risk Assessment for New Drug and Biological Products.
The Brazilian Health Regulatory Agency (ANVISA) has published a list of cannabis products that will have automatic approval by the agency for individual importation by Brazilian patients. The list also includes a large number of CBD preparations.