Guideline Knowledge Base

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201 matches

Sponsor's report on the maintenance of the designation criteria at the time of marketing authorisation for a designated orphan-medicinal-product

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

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Scientific aspects and working definitions for the mandatory scope of the centralised procedure

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

Latest version View timeline
Request for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004' to be replaced by 'Briefing Note and Recommendations on a Request for Accelerated Assessment Pursuant to Article 14 (9) of Regulation (EC) No 726/2004 - Template

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

Latest version View timeline
Rapid alert notification of a quality defect / recall

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation/good-distribution-practice).

GDP EMA

Latest version View timeline
Questions and answers: improving the understanding of normal operating range (NOR), proven acceptable range (PAR), design space (DSp) and normal variability of process parameters (EMA/CHMP/CVMP/QWP/354895/2017)

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

Latest version View timeline
Questions and answers on the procedure of PIP compliance verification at EMA, and on paediatric rewards

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

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

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers).

GDP EMA

Latest version View timeline
Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies - Final

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers).

GDP EMA

Latest version View timeline
Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance).

GMP EMA

Latest version View timeline
Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different ...

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers).

GDP EMA

Latest version View timeline

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GMP for Mid-Level Management in the Pharmaceutical Industry

GMP Training for Middle Management – Pharmaceutical Industry (Belgium)

Guideline Knowledge Base

Available Guidelines

Sponsor's report on the maintenance of the designation criteria at the time of marketing authorisation for a designated orphan-medicinal-product

Scientific aspects and working definitions for the mandatory scope of the centralised procedure

Request for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004' to be replaced by 'Briefing Note and Recommendations on a Request for Accelerated Assessment Pursuant to Article 14 (9) of Regulation (EC) No 726/2004 - Template

Rapid alert notification of a quality defect / recall

Questions and answers: improving the understanding of normal operating range (NOR), proven acceptable range (PAR), design space (DSp) and normal variability of process parameters (EMA/CHMP/CVMP/QWP/354895/2017)

Questions and answers on the procedure of PIP compliance verification at EMA, and on paediatric rewards

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

Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies - Final

Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation

Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different ...

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