The National Agency for Pharmaceutical Products (ANPP) plays a crucial role in enhancing pharmaceutical production. This organization, which has a significant responsibility for public health, is boosting its capabilities by establishing two regional annexes in Oran and Constantine. In this interview, Dr. Cherif Delih, the General Manager, discusses the Agency’s missions and objectives.
Three years after its creation, the National Agency for Pharmaceutical Products (ANPP) has major expansion plans. What does this mean for the market?
The regional annex in Oran, set to open on November 1st, will employ 150 executives and oversee the pharmaceutical market in 16 wilayas. This initiative aims to enhance capacity and decentralize technical operations. It’s important to note that these projects had been on hold for twelve (12) years. The completion of these projects demonstrates the political will and commitment of the Minister of Industry and Pharmaceutical Production, Mr. Ali Aoun, to develop the local pharmaceutical market,with a view to invest in the African market. Constantine, like Oran, serves as a hub for the pharmaceutical industry, hosting some of our largest pharmaceutical establishments.
These annexes will provide local services to operators, offering support and addressing their needs and requests. This approach will eliminate the need for operators to travel, reduce validation and processing times, minimize supply disruptions, and ensure the quality of products introduced to the market. These annexes also serve as hospital-university vocation. They serve as training grounds, especially for pharmacy students. They will thus meet absorb the demand for training and boost research activities by establishing partnerships with local and international universities.
What role does the National Agency for Pharmaceutical Products (ANPP) play in national production?
We assist manufacturers in registering and qualifying their products. This is achieved through the validation of quality control laboratories, which verify the quality and safety of pharmaceutical products before they are released to the market. The National Agency for Pharmaceutical Products (ANPP), through its experts, validates products by ensuring they are of high quality, comply with established specifications, and provide genuine medical benefits without presenting any risks.
The production of insulin and, in the near future, anti-cancer drugs represents a significant step forward. What is the rate of penetration of the national market?
70% of the products are manufactured locally, covering a significant portion of outpatient drugs. This is enormous. It’s important to note that during the COVID-19 pandemic, which exposed the issues of medicine and health-care product shortages caused by globalization, we managed an unprecedented situation thanks to our national manufacturing and stockpiling. Admittedly, there were supply disruptions on a limited number of drugs, due to a global crisis. Nevertheless, we were able to overcome all these challenges.
Since the National Agency for Pharmaceutical Products (ANPP) gained autonomy, the number of imported products that have been transitioned to local production has increased to 88. That’s a significant step forward. It’s clear that the sector has made significant qualitative and quantitative progress. The Saidal Group, which operates under the supervision of the Ministry of Health, is dynamically shifting from a focus on scientific research to technological development and innovation. Other establishments will soon be launching the production process for cancer drugs, insulin and low-molecular-weight heparin.
Could you clarify why your institution was established by law rather than by decree?
Unlike other institutions created by decree, The National Agency for Pharmaceutical Products (ANPP) is the only one created by law. The law assigned to it all the responsibilities that were previously under the jurisdiction of the National Laboratory for Control of Pharmaceutical Products (LNCPP) and the pharmacy department of the Ministry of Health. These include registration of pharmaceutical products, homologation of medical devices, expertise and control, and inspection of pharmaceutical establishments. The law is crystal clear: no product can be marketed without being registered, except in the case of a Temporary Use Authorization (TUA). Registration is mandatory, and when a product is set to be marketed, the National Agency for Pharmaceutical Products (ANPP) is responsible for releasing the batches.
Is the registration decision limited to a specific duration?
Five (05) years. Beyond that, there may be changes for instance in the indication or design of the product. Things evolve, and some molecules are no longer used worldwide. After this period, pharmaceutical establishments must submit an update file, in which the latest data are specified. And as you have probably noticed, some treatments are replacing others, and some laboratories are disappearing or merging with others.
Additionally, products may be quarantined if regular inspections reveal non-compliance with the commitments outlined in the registration file. The National Agency for Pharmaceutical Products (ANPP) evaluates the pharmaceutical file on multiple levels: quality, clinical data for brand-name drugs, and bioequivalence for generics. It also verifies the ingredients used in the production of the medicine, focusing specifically on the manufacturing method and process.
Registration is a complex phase because the product in question is a medication intended to offer therapeutic benefits to patients. The process involves several stages, which are outlined as follows: pre-submission, admissibility review, technical and administrative evaluation, and quality control. In terms of numbers, the National Agency for Pharmaceutical Products issued 398 registration decisions (RDs) in 2021, 664 RDs in 2022, and 997 RDs in 2023, as of September 30th. A total of 2,059.
How should we interpret the fact that products already released are later quarantined? Can you tell us how many medicines have been removed from the market?
In fact, not many. We communicate widely and quickly as soon as such a measure is taken. Withdrawing batches is a beneficial measure for public safety and the credibility of the pharmaceutical establishment. It is not a sanction, but rather a preventive measure, taken in response to an alert or following unannounced visits by the National Agency for Pharmaceutical Products (ANPP) concerned departments. This is a crucial step in ensuring that products released to the market comply with standards. If, during an inspection, we find any deviation, non-conformity, or failure to meet the commitments made during the registration process, we proceed with the withdrawal of the batches.
Algerian regulations are clear. The product must be identical to the one inspected during registration. A responsibility toward citizens. We must provide prescribers with reliable drug treatments. This is why samples are collected during inspections, after which expert reports are established. Approval specifies the place of manufacture, conditions, and adherence to standards. Medicines produced at unauthorized sites or change in the supply of active ingredients are among the reasons that could lead to the temporary closure of a pharmaceutical establishment.
Also included are products confiscated by Customs and the National Security Directorate (DGSN). Are these also subject to National Agency for Pharmaceutical Products (ANPP) controls?
Seized Products, such as those commonly referred to as bootleg goods, are considered a criminal offense. They are neither registered nor imported by licensed pharmaceutical establishments with proper authorization. They are not part of any import program and have not been authorized for marketing by the National Agency for Pharmaceutical Products.
During times of shortage, these products have been reported to save lives. What do you have to say about this?
We are responsible for ensuring the safety of our citizens regarding everything that is placed on the market. Thus, we cannot endorse such practices. We do not know their source, nor whether they’ve been stored under appropriate conditions. We should not forget that these are chemical products, which can have side effects.
The Head of State consistently emphasizes that digitization is a crucial criterion. What stage is the sector at?
We began the process of digitization quite some time ago. Payment slips have been digitally indexed for the past three (03) years. Currently, we’re getting ready for the next phase, which is pre-submission. The current project will include the digitization of pharmaceutical files in accordance with the Common Technical Document (eCTD) format and international standards. Dematerialization is a national priority to reduce processing times and save physical space.
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