Posted by US FDA: Withdrawal of draft guidance on electronic submission of manufacturing establishment information
CDSCO constitutes committees Medical Device Advisory Group.
Information on batch testing of medicinal products in the context of withdrawal of the United Kingdom from the Union
BP and USP formalize partnership to strengthen quality of medicines and public health
MHRA: Clinical investigations of medical devices – biological safety assessment in line with EU MDR
US FDA: SAFE IMPORTATION ACTION PLAN
FDA: Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers
FDA: Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labelling Recommendations Guidance for Industry
NMPA: Expansion of pilot system of medical device registrants
ICMRA: Statement from global medicines regulators on combatting antimicrobial resistance
TGA: Therapeutic goods advertising
TGA: Best practice for Patient Information Leaflets and Patient Implant Cards
IMDRF: Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
EMA: Updated reminder on the working documents provided within the eCTD submissions
Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no-deal Brexit
Safety reporting during clinical trials in South Africa
TGA: GMP Clearance applications using Health Canada evidence
TGA: GMP Clearance applications using Health Canada evidence
TGA: Reformatting Product Information: Frequently asked questions
FDA: Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry
FDA: Child-Resistant Packaging Statements in Drug Product Labelling Guidance for Industry
EC: Designates Third Notified Body Under MDR
FDA: Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry
UK: New service to deliver urgent medicines and medical products into UK
UK: List of approved countries for authorised human medicines on exit day
Germany Permits Clinical Trial Filings via Common European Submission Portal (article in German)
Germany’s Federal Institute for Drugs and Medical Devices (BfArM) has started to accept applications to run clinical trials through Common European Submission Portal (CESP). This will serve as a better option compared to the current practice of submitting paper applications and DVDs.
Applicants who use CESP for submitting clinical trial request need not submit paper or DVD version. But companies which wish to submit only paper or DVD copies are still acceptable.
Swissmedic: Modification of various documents relating to authorization
NAMMDR increases marketing authorization fee
New APEC survey: More regulatory approval of medicinal products
Pre-Assigned Number Requests via CDER’s Portal
Reporting Threshold in USP-NF Monographs: Proposed Policy Change for Public Comment
CDER Plots Pilot Project to Test CDISC Standard
EC includes IMQ as fourth Notified Body designated under MDR
European Commission (EC) on Tuesday added Milan, Italy-based IMQ Institute to its list of notified bodies (NBs) designated under the new Medical Devices Regulation (MDR).
CDSCO seeks feedback on mandatory use of QR codes on API packaging
Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country
FDA: Clinical Outcome Assessment Compendium
MHRA: Assistive technology, definition and safe use
European Medicines Agency procedural advice for users of the centralised procedure for generic/hybrid applications
ANSM to implement new procedures for processing national approval filings (article in French)
The French National Agency for Medicines and Health Products Safety (ANSM) is all se to implement new procedure for processing national marketing authorization applications from 01st October.
ANSM has drafted the process to confirm compliance with regulatory deadlines. In situations where ANSM requires additional data or information to evaluate a filing, applicant will be provided 14 days to submit the requested materials. ANSM will not consider the applications if the companies fail to submit before the due time.
To ensure the availability of all data at the time of filing application, ANSM encourages applicants to use the EMA’s checklist for centralized process to check the completeness and compliance against the requirement.
MHRA Drops Paper and Email, Restricting Communications to web Portals
SwissPAR HMV4 guidance document modified
Danish regulators come up with new concept for guidance on medical device rules
CDSCO extends deadline to manufacturers of rational FDCs for seeking clearance
CDSCO clarifies questions on importing drugs for academic use
TGA: Help us promote adverse event reporting: promotional resources kit
FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease
FDA: Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products (draft guidance)
FDA: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions