WHO boosts pharma regulation capacity

Published: 16-Feb-2015

This has become increasingly important as pharmaceutical manufacturing and distribution becomes more globalised


The World Health Organization (WHO) has staged a three-day consultation meeting aimed at strengthening pharmaceutical regulatory systems worldwide.

Taking place between 13–15 January at its headquarters in Geneva, Switzerland, the WHO is undertaking a programme of building and strengthening regulatory capacity in its member states. Its goal, said the European Medicines Agency (EMA), is to 'cover all product areas and health technologies, including medicines, vaccines, medical devices, diagnostics, and traditional medicines'.

EMA added that strengthening regulatory capacity has become increasingly important as pharmaceutical manufacturing and distribution becomes more globalised, and is key to ensuring access to medicines of assured quality.

The Agency used the meeting to explain the good practice associated with its 'Benchmarking of European Medicines Authorities' initiative, launched with European Union (EU) national medicines agencies in 2003.

The WHO has a formal role in improving medicine regulation worldwide. It helps develop internationally-recognised norms, standards and guidelines; and it also undertakes guidance, technical assistance and training on pharmaceutical regulation, especially helping developing countries implement these global guidelines.

A WHO note on the issue stressed that governments should establish strong national medicines regulatory authorities 'with [a] clear mission, solid legal basis, realistic objectives, appropriate organisational structure, adequate number of qualified staff, sustainable financing, access to up-to-date evidence based technical literature, equipment and information, [and the] capacity to exert effective market control'. They should be accountable to their governments and the public, making decisions transparently.

'Monitoring and evaluation mechanisms should be built into the regulatory system to assess attainment of established objectives,' said the WHO.

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