HMPC adopts revised Quality Guidelines for Herbal Medicinal Products

At the 101th HMPC meeting, held from 20-22 September 2021, the herbal medicinal products committee (HMPC) of the EMA adopted the following revised guidance documents:

  • Guideline on quality of herbal medicinal products / traditional herbal medicinal products (EMA/HMPC/201116/2005 Rev. 3) 
  • Guideline on Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products (EMA/HMPC/162241/2005 Rev. 3)

Will the written GACP declaration now become a requirement?

The consultation document on the quality of HMPs included, amongst others, the following new requirement: "A written GACP declaration for the herbal substance should be provided by the manufacturer of the active substance or the HMP, as appropriate."

However, the final documents still need to be adopted in addition by the CHMP and CVMP and will then be published on EMA´s Herbal medicinal products: scientific guidelines website together with an overview of comments received during the public consultation.

In addition, the HMPC recently announced to revise the Guideline on Good Agricultural and Collection Practice (GACP) in order to address stakeholder requests on required clarifications, e.g. overlap GMP vs. GACP. 

Please see the 101th HMPC meeting report on European Union herbal monographs, guidelines and other activities for further information.

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