Snapshot

The Registration of Advanced Therapy Products pathway has been developed by the Department of Health (DH) of Hong Kong.

This pathway can be used where advanced therapy products..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Austria Belgium Bulgaria Canada Cyprus Czech Republic Denmark EU-EMA Estonia Finland France Germany Greece Holland Hungary Ireland Italy Japan Latvia Lithuania Luxembourg Malta Poland Portugal Romania Slovakia Spain Sweden Switzerland United Kingdom United States

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