To strengthen pharmaceutical production, the role of the National Agency of Pharmaceutical Products (ANPP) is fundamental. This institution, part guarantor of public health, is consolidating its capacities through the creation of two regional annexes in Oran and Constantine. In this interview, its Director General Dr. Chérif Delih, talks about the Agency’s missions and objectives.
Three years after its creation, ANPP has major expansion plans. What does this means for the market?
The regional annex in Oran, scheduled to open on November 1, will employ 150 officers and supervise the market in 16 wilayas, reinforcing capacity and decentralizing technical activities . It should be pointed out that these projects have been frozen for 12 years. Their realization reflects the political will and commitment of the Minister of Industry and Pharmaceutical Production, Mr. Ali Aoun, to develop the local pharmaceutical market, with plans to invest in the African market. Constantine, like Oran, is a center of pharmaceutical industry, hosting some of our largest pharmaceutical establishments.
These annexes will offer a local services to operators, supporting them and responding to their requests. This will avoid the need for operators to travel, reduce validation and processing times and any supply disruptions, and guarantee the quality of palliatives brought to market. These annexes also serve as hospital-university vocation. These are learning grounds for pharmacy students, in particular. In this way, they will absorb the demand for training and boost research, by signing agreements with local and foreign universities.
What role does ANPP play in national production?
We support producers in registering and qualifying their products. This is done via the validation of quality control laboratories, which verify the quality and safety of pharmaceutical products before they are released to the market. Through its experts, ANPP validates products, i.e whether it is of high quality, meets the specific requirements set out in the documents, and offers a real medical service without presenting any-danger.
The production of insulin and, in the near future, anti-cancer drugs is considered a huge step forward. What is the penetration rate in the domestic market?
seventy percent of the products are manufactured locally,including most of the city’s drugs. What an achievement. It should be noted that during covid-19 panademic, which crystallized the problems of shortages of drugs and health products due to globalization, we managed an unprecedented situation thanks to domestic manufacturing and stocks. Admittedly, there have been supply disruptions on a limited number of drugs, due to a global crisis. However, we were able to overcome all these difficulties.
Since ANPP became autonomous, the number of imported products coverted to local production has risen to 88. It,s a great evolution . It has to be said that the sector has made a qualitative and quantitative leap forward. Saidal Group, which operates under the supervision of the Ministry of Industry, is making a dynamic transition from scientific research to technological development and innovation. There are also plants taht will soon be launching the production process for cancer drugs, insulin and low-molecular-weight heparin.
Could you clarify why your institution was created by law and not by decree?
Unlike other institutions created by decree, The ANPP is the only one created by law. The law entrusted it with all the missions previously carried out by the National Laboratory for the Control of Pharmaceutical Products (LNCPP) and those of the pharmacy diretorate at the Ministry of Health. These include registration of pharmaceutical products, homologation of medical devices, expertise and control, and inspection of pharmaceutical companies. The law is clear: no product can be placed without being registered, except under exceptional circumustances in the case of a Temporary Use Authorization (TUA). Registration is compulory, and the ANPP releases the batches when they are placed on the market.
Concerning the registration decision, is it limited to a specific period ?
Five years. Beyond that, there may be changes in indication or design. Things are changing, and some molecules are no longer used anywhere in the world. After this deadline, pharmaceutical companies 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.
In Addition, products may be quarantined if regular checks reveal non-compliance with the commitments signed in the registration file. The Anpp evaluates the pharmaceutical file on all levels: quality, clinical aspects for originator drugs, bioequivelence for generics. There is the verification of the inpus, which go into the manufactures the drug, and more specifically the method of manufacture, the process.
Registration is a complex process because it is the drug product that has to take care of a patient’s therapy. several stages are described: pre-submission, admissibility, technical and administrative evaluation, and quality control. In figures, The ANPP will have issued 398 registration decisions (RDs) in 2021, 664 RDs in 2022, and 997 RDs in 2023, as at September 30th. In total of 2,059.
How can we preceive the fact that released products are subsequently quarantined ? Can you tell us how many treatments have been withdrawn from the market?
Actually, not very much. We communicate widely and quickly as soon as such a measure is taken. Withdrawing batches is a beneficial measure for citizens and the credibility of the pharmaceutical company. This is not a sanction, but rather a preventive measure, taken following an alert or following unannounced visits by The ANPP departements concerned. This is an essentiel step in verifying the conformity of products placed on the market. If, during the inspection, we find any deviation, non-conformity, or non-compliance with the commitments made when the application was submitted, we will withdrawthe batches.
Algerian regulations are clear. The product must be identical to the one checked at registration. it is our responsibility toward citizens. We need to put reliable drug treatments in the hands of prescribers. This is why samples are taken during inspections, after which expert reports are drawn up. The authorization stipulates the manufacturing location, conditions and compliance with standards. Drugs produced on unauthorized sites, or a change in the supply of active ingredients, are just some of the reasons for temporary closure of a pharmaceutical establishment.
Moreover, there are products seized by Customs and the National Security Directorate (DGSN). Are they also monitored by the ANPP ?
Seized Products, such as those commonly referred to as ‘cabas’ (meaning drugs coming in shopping bags), considered a criminal offence. They are not registered and are not imported by authorized pharmaceutical companies holding a trade register certeficate. They are not part of any import program and have not been authorized for marketing by the ANPP.
In times of shortage, these products have saved lives. According to testimonials. What do you think?
We are guarantors of our citizens’ safety with regard to everything that is put on the market. As result, we cannot endorse these practices. We do not know where they come from, or whether they have respected the storage conditions. Not to mention that these are chemicals, which can have side effects.
The Head of State constantly stresses that digitization is an imperative. What is the current state of the sector?
We embarked digitization a long time ago. Payment slips have been digitally indexed for the past three years. Currently, we’re preparing for the next stage, pre-submission. The current project will digitize pharmaceutical files in line with the Common Technical Document (CTD) format and international standards. Dematerialization is a national challenge to reduce processing times and save space.
Interview by Samira Azzegag
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