Regulatory Update – August 2019

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US FDA: Withdrawal of draft guidance on electronic submission of manufacturing establishment information

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CDSCO constitutes committees Medical Device Advisory Group.

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Information on batch testing of medicinal products in the context of withdrawal of the United Kingdom from the Union

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BP and USP formalize partnership to strengthen quality of medicines and public health

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 MHRA: Clinical investigations of medical devices – biological safety assessment in line with EU MDR

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US FDA: SAFE IMPORTATION ACTION PLAN

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FDA: Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers

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FDA: Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labelling Recommendations Guidance for Industry

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NMPA: Expansion of pilot system of medical device registrants

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 ICMRA: Statement from global medicines regulators on combatting antimicrobial resistance

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TGA: Therapeutic goods advertising

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TGA: Best practice for Patient Information Leaflets and Patient Implant Cards

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IMDRF: Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

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EMA: Updated reminder on the working documents provided within the eCTD submissions

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Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no-deal Brexit

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Safety reporting during clinical trials in South Africa

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TGA: GMP Clearance applications using Health Canada evidence

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TGA: GMP Clearance applications using Health Canada evidence

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TGA: Reformatting Product Information: Frequently asked questions

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FDA: Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry

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FDA:  Child-Resistant Packaging Statements in Drug Product Labelling Guidance for Industry

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EC:  Designates Third Notified Body Under MDR

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FDA: Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry

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UK: New service to deliver urgent medicines and medical products into UK

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UK: List of approved countries for authorised human medicines on exit day

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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

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NAMMDR increases marketing authorization fee

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New APEC survey: More regulatory approval of medicinal products

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Pre-Assigned Number Requests via CDER’s Portal

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Reporting Threshold in USP-NF Monographs: Proposed Policy Change for Public Comment

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 CDER Plots Pilot Project to Test CDISC Standard

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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

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Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country

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FDA:  Clinical Outcome Assessment Compendium

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MHRA: Assistive technology, definition and safe use

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European Medicines Agency procedural advice for users of the centralised procedure for generic/hybrid applications

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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

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SwissPAR HMV4 guidance document modified

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Danish regulators come up with new concept for guidance on medical device rules

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CDSCO extends deadline to manufacturers of rational FDCs for seeking clearance

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CDSCO clarifies questions on importing drugs for academic use

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TGA: Help us promote adverse event reporting: promotional resources kit

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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

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FDA:  Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products (draft guidance)

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FDA: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions

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