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Compliance: Overview

All organisations involved in the development, marketing, manufacture and distribution of medicines are responsible for ensuring that they comply with all relevant standards set out in European Union (EU) legislation and guidelines on pharmaceuticals. The European Medicines Agency (EMA) is responsible for harmonising these standards at EU level. It also coordinates inspections to verify compliance.

EMA's role

EMA coordinates inspections for human and veterinary medicines authorised under the centralised procedure or in the context of a referral, on request from the Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP).

EMA does not conduct inspections itself but requests that the inspection be carried out by national authorities in the EU Member States.

EMA is the primary contact point for reporting a suspected quality defect?with any centrally authorised product?and is responsible for coordinating the investigation, evaluation and follow-up of such cases.

EMA also operates a?Sampling and testing programme to verify the quality of centrally authorised medicines placed on the market and to check their compliance with their authorised specifications.

In addition, EMA plays a key role is in coordinating and harmonising EU-wide activities, including:

  • developing and harmonising standards at EU level;
  • developing EU guidelines on inspections and related procedures;
  • preparing guidance through inspectors working groups;
  • coordinating advice on the interpretation of regulatory requirements.

Inspections: verifying compliance

Authorities in the EU regularly inspect sites within and outside the EU involved in developing, manufacturing and distributing human or veterinary?medicines intended for the EU market, to verify their compliance with the relevant standards.

These inspections ensure?that the rights, safety and wellbeing of clinical-trial subjects are protected,?and?the reliability and integrity of data that support the authorisation of medicines and their quality, safety and effectiveness once on the market.

An inspection may either be 'for cause', when it is triggered by a finding of possible non-compliance with relevant standards, or routine, when inspections are carried out as part of a surveillance programme.

Inspections are conducted both for authorised medicines and for medicines?under evaluation in the EU.

Update: An overview of the different types of inspection EMA's CHMP can request as part of the assessment and monitoring of human medicines under the centralised authorisation procedure is available below.

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