The National Agency for Pharmaceutical Products (ANPP) has implemented new measures designed to simplify the registration process for pharmaceutical manufacturers. These changes aim to benefit industrial operators in the pharmaceutical sector by streamlining the procedures for registering ready-to-use pharmaceutical products.
The streamlined process applies to both domestically manufactured and imported pharmaceutical products, as well as those intended for export. All such products are required to undergo a registration process with the ANPP before they can be marketed.
Under the new system, pharmaceutical product registration files will be presented to the Drug Registration Committee only once. If the committee raises objections, the registration file will be suspended until the pharmaceutical company addresses and resolves all concerns. Once the concerns are resolved, the registration decision will be issued without requiring the file to be re-submitted to the Registration Committee.
This procedural change is intended to reduce bureaucratic hurdles within the ANPP regarding the issuance of registration decisions, while ensuring full compliance with existing legal and regulatory frameworks. The ANPP aims to facilitate a more efficient and transparent registration process for pharmaceutical products in Algeria.
These changes are expected to positively impact the pharmaceutical industry, encouraging both local production and investment in the sector. By simplifying the registration process, the ANPP hopes to ensure timely access to essential medicines for the Algerian population.
