Tag: ema

GMP-Audits of manufacturers of active substances: Minimum Requirements on Audit Reports and Qualification of Auditors

https://seetharamkandarpa.webnode.in/news/gmp-audits-of-manufacturers-of-active-substances-minimum-requirements-on-audit-reports-and-qualification-of-auditors/

Guideline on the European Drug Master File Procedure updated

https://seetharamkandarpa.webnode.in/news/guideline-on-the-european-drug-master-file-procedure-updated/

Final EMA Variations Guideline on Procedures Issues and Classification of Variations published

https://seetharamkandarpa.webnode.in/news/final-ema-variations-guideline-on-procedures-issues-and-classification-of-variations-published/

EU-GMP: New Annex 16 released

https://seetharamkandarpa.webnode.in/news/eu-gmp-new-annex-16-released/

Written Confirmation: A Questions & Answer Document of the Danish Authority provides further Clarifications

https://seetharamkandarpa.webnode.in/news/written-confirmation-a-questions-answer-document-of-the-danish-authority-provides-further-clarifications/

New EMA Inspection Requirements on Good Distribution Practices (GDP)

https://seetharamkandarpa.webnode.in/news/new-ema-inspection-requirements-on-good-distribution-practices-gdp-/

Variations: Important Changes in the New Application Form

https://seetharamkandarpa.webnode.in/news/variations-important-changes-in-the-new-application-form/

New EMA Guideline on Starting Materials from Biological Medicinal Products

https://seetharamkandarpa.webnode.in/news/new-ema-guideline-on-starting-materials-from-biological-medicinal-products/

Updated Procedure for the Renewal and Revision of CEPs!

https://seetharamkandarpa.webnode.in/news/updated-procedure-for-the-renewal-and-revision-of-ceps-/

EMA Guideline on the use of bovine serum in the manufacture of human biological medicinal products

https://seetharamkandarpa.webnode.in/news/ema-guideline-on-the-use-of-bovine-serum-in-the-manufacture-of-human-biological-medicinal-products/

Frequently asked GMP question: How should active substance auditors be qualified?

https://seetharamkandarpa.webnode.in/news/frequently-asked-gmp-question-how-should-active-substance-auditors-be-qualified-/

EMA publishes Guideline on Pharmaceutical Development of Medicines for Paediatric Use

https://seetharamkandarpa.webnode.in/news/ema-publishes-guideline-on-pharmaceutical-development-of-medicines-for-paediatric-use/

Quality by Design: Lessons learnt from EMA/FDA Pilot Program

https://seetharamkandarpa.webnode.in/news/quality-by-design-lessons-learnt-from-ema-fda-pilot-program/

EMA published Concept Paper on the Revision of the Finished Dosage Form Guideline

https://seetharamkandarpa.webnode.in/news/ema-published-concept-paper-on-the-revision-of-the-finished-dosage-form-guideline/

EMA Guideline on Quality of biological active Substances produced by transgene Expression in Animals

https://seetharamkandarpa.webnode.in/news/ema-guideline-on-quality-of-biological-active-substances-produced-by-transgene-expression-in-animals/

EMA publishes revised dossier-submission requirements for active-substance master files

https://seetharamkandarpa.webnode.in/news/ema-publishes-revised-dossier-submission-requirements-for-active-substance-master-files/

European Medicines Agency and US Food and Drug Administration release further guidance on quality-by-design approach

https://seetharamkandarpa.webnode.in/news/european-medicines-agency-and-us-food-and-drug-administration-release-further-guidance-on-quality-by-design-approach/

EMA now also issues GMP and GDP Non-Compliance Information

https://seetharamkandarpa.webnode.in/news/ema-now-also-issues-gmp-and-gdp-non-compliance-information/

How to submit an Active Substance Master File?

https://seetharamkandarpa.webnode.in/news/how-to-submit-an-active-substance-master-file-/

Update: Electronic Submission of Marketing Authorisation Dossiers

https://seetharamkandarpa.webnode.in/news/update-electronic-submission-of-marketing-authorisation-dossiers/

GCP and Bioequivalence Studies: new FDA/EMA Initiative

https://seetharamkandarpa.webnode.in/news/gcp-and-bioequivalence-studies-new-fda-ema-initiative/

New EMA Guidance Qualification of novel Methodologies for Drug Development

https://seetharamkandarpa.webnode.in/news/new-ema-guidance-qualification-of-novel-methodologies-for-drug-development/

My new Mobile Application "SRK GCP World"

https://seetharamkandarpa.webnode.in/news/my-new-mobile-application-srk-gcp-world/

New Process Validation Guideline by EMA

https://seetharamkandarpa.webnode.in/news/new-process-validation-guideline-by-ema/

New EMA Guideline on Stability Testing for Applications for Variations

https://seetharamkandarpa.webnode.in/news/new-ema-guideline-on-stability-testing-for-applications-for-variations/

EMA: Changes to Handling of Variations

https://seetharamkandarpa.webnode.in/news/ema-changes-to-handling-of-variations/

Draft Guideline on Validation of biotechnology-derived Products by EMA

https://seetharamkandarpa.webnode.in/news/draft-guideline-on-validation-of-biotechnology-derived-products-by-ema/

Qualification of a Responsible Person for GDP- UK Gold Standard

https://seetharamkandarpa.webnode.in/news/qualification-of-a-responsible-person-for-gdp-uk-gold-standard/

EMA Official Details Obstacles to Reaching Mutual Reliance on GMP Inspections

https://seetharamkandarpa.webnode.in/news/ema-official-details-obstacles-to-reaching-mutual-reliance-on-gmp-inspections/

HMPC Q&A Documents on Herbal Medicinal Products

https://seetharamkandarpa.webnode.in/news/hmpc-q-a-documents-on-herbal-medicinal-products/

Final QP Declaration Template by EMA

https://seetharamkandarpa.webnode.in/news/final-qp-declaration-template-by-ema/

New Procedure for co-ordinating GCP-Inspections by CHMP

https://seetharamkandarpa.webnode.in/news/new-procedure-for-co-ordinating-gcp-inspections-by-chmp/

GMP Non-compliance reports (AGEPHA, Austria) Published by EMA

https://seetharamkandarpa.webnode.in/news/gmp-non-compliance-reports-agepha-austria-published-by-ema/

GMP Non-compliance reports (North China Pharmaceutical Group Semisyntech Co., Ltd, China) Published by EMA

https://seetharamkandarpa.webnode.in/news/gmp-non-compliance-reports-north-china-pharmaceutical-group-semisyntech-co-ltd-china-published-by-ema-/

Update of Guideline on the packaging information of medicinal products for human use authorised by the Union (July 2015) [EudraLex - Volume 2]

https://seetharamkandarpa.webnode.in/news/update-of-guideline-on-the-packaging-information-of-medicinal-products-for-human-use-authorised-by-the-union-july-2015-eudralex-volume-2/

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

https://seetharamkandarpa.webnode.in/news/european-medicines-agency-pre-authorisation-procedural-advice-for-users-of-the-centralised-procedure/

Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances

https://seetharamkandarpa.webnode.in/news/reflection-paper-on-the-chemical-structure-and-properties-criteria-to-be-considered-for-the-evaluation-of-new-active-substance-nas-status-of-chemical-substances/

EMA revises Guide on Pharmaceutical Water

https://seetharamkandarpa.webnode.in/news/ema-revises-guide-on-pharmaceutical-water/

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 April 2017

https://seetharamkandarpa.webnode.in/news/meeting-highlights-from-the-committee-for-medicinal-products-for-human-use-chmp-18-21-april-2017/

Regulatory information - adjusted fees for applications to EMA from 1 April 2017

https://seetharamkandarpa.webnode.in/news/regulatory-information-adjusted-fees-for-applications-to-ema-from-1-april-2017/

EMA Q&A on GCP

https://seetharamkandarpa.webnode.in/news/ema-q-a-on-gcp/

Brexit preparedness: EMA to further temporarily scale back and suspend activities

https://seetharamkandarpa.webnode.in/news/brexit-preparedness-ema-to-further-temporarily-scale-back-and-suspend-activities/

Targeted stakeholder consultation on the draft Guidelines on Good Clinical Practice for Advanced Therapy Medicinal Products

https://seetharamkandarpa.webnode.in/news/targeted-stakeholder-consultation-on-the-draft-guidelines-on-good-clinical-practice-for-advanced-therapy-medicinal-products/