EMA Updates on 3Rs Guideline Review
Regulatory News | 04 December 2018 |
The European Medicines Agency (EMA) on Tuesday published a report on actions taken to update its guidelines following a review of 3Rs, or replacement, reduction and refinement, principles to reduce the need for animal testing of medicinal products.
In 2014, EMA’s Committee for Medicinal Products for Human Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP) launched a review to update their guidelines to ensure they align with 3Rs best practices. The review was not meant to reconsider testing requirements, “but, rather, to ensure that EMA guidelines do not make reference to animal tests that are no longer considered appropriate,” the report says.
EMA also drafted a default 3Rs statement to include in the Legal Basis section of relevant guidelines, though the agency says there will be some flexibility to use a modified statement in certain guidelines.
The default statement reads: “In accordance with the provisions of the European Convention for the protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes and Directive 2010/63/EU on protection of animals used for scientific purposes, the 3R principles (replacement, reduction and refinement) should be applied to regulatory testing of medicinal products.”
Updated Guidelines
Because most of the guidelines overseen by the Joint CHMP/CVMP Quality Working Party (QWP) relate to physical or physiochemical quality control issues or technical procedures, the QWP concluded that its current guidelines are in line with 3Rs best practices and do not need to be updated.
Similarly, the Committee for Advanced Therapies (CAT) found that none of its guidelines needed to be updated to align with 3Rs best principles. “A stepwise and risk-based approach is recommended for advanced therapy medicinal products (ATMPs) giving preference to in vitro models. If an animal model is necessary, only a relevant one should be performed,” the report says. The CHMP Vaccines Working Party (VWP) also found its guidelines did not need to be updated with regard to 3Rs principles.
For guidelines overseen by the CHMP Biologicals Working Party (BWP), three guidelines were updated to include a 3Rs statement and to emphasize in vitro methods to reduce the need for animal testing for biological activity and potency.
For biosimilars, the CHMP Biosimilar Medicinal Products Working Party (BMWP) updated three of its guidelines and is in the process of revising two others to “include the stepwise approach for evaluation of the similarity of the biosimilar and the reference product which means that analytical studies and in vitro pharmaco-toxicological studies should be conducted first and a decision then made as to the extent of what, if any, in vivo work in animal studies will be required.”
According to the CHMP Safety Working Party (SWP-H), five International Council for Harmonization (ICH) safety guidelines are either being revised or have been finalized with consideration for 3Rs principles and a sixth ICH guideline, ICH S7B: Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization, is planned for revision.
For veterinary medicines, the CVMP Immunologicals Working Party (IWP), Safety Working Party (SWP-V) and Efficacy Working Party (EWP-V) each updated or are in the process of revising some of their guidelines.
EMA
In 2014, EMA’s Committee for Medicinal Products for Human Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP) launched a review to update their guidelines to ensure they align with 3Rs best practices. The review was not meant to reconsider testing requirements, “but, rather, to ensure that EMA guidelines do not make reference to animal tests that are no longer considered appropriate,” the report says.
EMA also drafted a default 3Rs statement to include in the Legal Basis section of relevant guidelines, though the agency says there will be some flexibility to use a modified statement in certain guidelines.
The default statement reads: “In accordance with the provisions of the European Convention for the protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes and Directive 2010/63/EU on protection of animals used for scientific purposes, the 3R principles (replacement, reduction and refinement) should be applied to regulatory testing of medicinal products.”
Updated Guidelines
Because most of the guidelines overseen by the Joint CHMP/CVMP Quality Working Party (QWP) relate to physical or physiochemical quality control issues or technical procedures, the QWP concluded that its current guidelines are in line with 3Rs best practices and do not need to be updated.
Similarly, the Committee for Advanced Therapies (CAT) found that none of its guidelines needed to be updated to align with 3Rs best principles. “A stepwise and risk-based approach is recommended for advanced therapy medicinal products (ATMPs) giving preference to in vitro models. If an animal model is necessary, only a relevant one should be performed,” the report says. The CHMP Vaccines Working Party (VWP) also found its guidelines did not need to be updated with regard to 3Rs principles.
For guidelines overseen by the CHMP Biologicals Working Party (BWP), three guidelines were updated to include a 3Rs statement and to emphasize in vitro methods to reduce the need for animal testing for biological activity and potency.
For biosimilars, the CHMP Biosimilar Medicinal Products Working Party (BMWP) updated three of its guidelines and is in the process of revising two others to “include the stepwise approach for evaluation of the similarity of the biosimilar and the reference product which means that analytical studies and in vitro pharmaco-toxicological studies should be conducted first and a decision then made as to the extent of what, if any, in vivo work in animal studies will be required.”
According to the CHMP Safety Working Party (SWP-H), five International Council for Harmonization (ICH) safety guidelines are either being revised or have been finalized with consideration for 3Rs principles and a sixth ICH guideline, ICH S7B: Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization, is planned for revision.
For veterinary medicines, the CVMP Immunologicals Working Party (IWP), Safety Working Party (SWP-V) and Efficacy Working Party (EWP-V) each updated or are in the process of revising some of their guidelines.
EMA
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