The EDA issued Decree No. 343/ 2021 (Decree) regarding the rules and procedures for registering biological products, serums, vaccines and blood products; this was published in the Official Gazette No. (168 Annex/ 2021) on Sunday August 1st,2021.
The Egyptian Drug Authority (EDA) is keen to keep pace with modern scientific developments on an ongoing basis. The EDA has shown interest to keep pace of new biological preparations. It want to make it available while ensuring their quality, efficacy and safety. EDA has a stated goal of facilitating the registration procedures for all kinds of biological preparations. It seeks to work on the speedy delivery of biological preparations to the local market.
The decree defines biological products as “Preparations containing one or more active substances that are produced or extracted from a biological source, including, for example: human vaccines, serums, blood and plasma products and derivatives, as well as products manufactured using biotechnology and the like, as well as any preparations or materials that may be developed according to scientific advances and / or international standards and references”. The company applying to register a biological product must submit an undertaking ascertaining its compliance with the IPL No. 82 of 2002. If it turns that the company is in violation of the IPL the company would bear full responsibility. EDA would have the right to suspend the registration procedures or revoke the registration.
The Decree allows to grant the innovator, marketing authorization (MA) approval valid for five years. The MA may be extended once the innovator re-registers starting through the fifth year of the validity of the MA approval. The president of the EDA has the right to halt or to cancel the registration procedure or invalidate an already registered biological product if its use causes harm.
If the biological product is not available in the market for a continuous period of 18 month, the head of the Central Administration of Biological Products, Innovative Produces and Clinical trials (CA) may cancel the MA approval. If any batch is manufactured after the cancellation decision, the innovator shall be liable.
EDA recognizes that exceptional procedures merit early release of the biological products. Upon recommendation of the Vice President of EDA, the President of the EDA may exempt certain biological product from some of the registration requirements. In that case the CA shall acquire samples of the product. The innovator should provide the full registration file (Common Technical Document “CTD” file) within two months of the approval.
Any biological product already registered previously not by CTD and the Decree 297/2009 must be re-registered, analyzed and a full evaluation of a complete CTD will be done.
Dr. Gihan Taha