Overview:
Service Orientation (OS) 88/2020 provides details on procedures for reviewing documents required for submission of the Clinical Drug Development Dossier (DDCM) and changes that potentially impact the quality or safety of experimental drugs, active BE/BA drugs or placebos.
Service Orientation 88/2020
This OS applies to:
- Dossiers of products that have at least one clinical trial, at any stage of development, approved by at least one regulatory authority in a founding or permanent member country of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
- Dossiers of experimental drugs registered in at least one country that meets the above criteria.
- Substantial quality changes approved by at least one regulatory authority from any of the countries meeting the criteria in the first item.
Regulatory Corner:
- The provisions of this OS do not presuppose prioritizing the examination of petitions.
- The provisions of this OS may be applied to DDCM petitions and substantial quality modifications submitted prior to their publication, at the request of the Simplified Quality Dossier Analysis, provided that the petition is still in line awaiting the start of the technical analysis.
The experimental drug of the DDCM submitted at Anvisa shall be identical to that approved by the regulatory authorities of any of the countries that meet the criteria described in item I, except for the models of labels and secondary packaging.
The manufacturing process of the experimental drug shall meet the criteria and recommendations described in the current ICH guides, where applicable, according to the clinical development phase.
There is no requirement that the clinical trial mentioned in the first item be the same as the one submitted for consent in Brazil.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations. To learn more, please contact us at info@globalregulatorypartners.com
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https://globalregulatorypartners.com/case_studies/transfer-of-marketing-authorization-license-for-biologic-in-brazil/
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