Sidal complex bioequivalence center ends the pending crisis of drugs regestration 

 Transfer of 94 therapeutic categories from import to export among them cancer medications

The National Agency for Pharmaceutical Products director, Dr. Cherif DELIH has established a green corridor for the Central Pharmacy of Hospitals, by putting their medications under control and releasing them whithin a framework not exceeding three days, due to their priority to ensure their continuous availability.

Dr. DELIH declared in an interview with El-Massa newspaper: “The delay in supplying the Central Pharmacy of Hospitals with medications and blood derivatives is not due to delays in releasing medications batches, but rather to the procedures that should be followed to ensure safe healthcare products for patients.

A shortage in supplying the Central Pharmacy stores with medications has been recorded due to your agency’s delay in releasing medications batches. What is the reason behind this?

 I would like to clarify  that there is no delay in releasing medication batches for the Central Pharmacy of Hospitals, since the agency has implemented a green corridor for it, to ease the control procedures. Also, there are legal procedures to follow, starting with the technical reglatory phase followed by microbiologic control for blood derivatives. Thus, products are strictly controlled by Four certified national public laboratories. This kind of treatments cannot be released in a short period of time because of its rarity.

We are going to point out that, it is impossible to accelerate the biological control procedures which usually takes at least 16 days before getting the safety results. And I assure you that the agency would never be a reason of a medication deficiency in hospitals because of those control procedures. The simple reason for this is the obligation for the Central Pharmacy of Hospitals to maintain a reserve stock covering 90 days of worth needs.

What about temporary import permits for medications?

Regarding the temporary import permits for medications, which the Central Pharmacy of Hospitals delivers, they are decreasing due to the increase of the local medication manufacturing.

How many drug registration decisions have been delivered?

Drug registration decisions reached 1010 decisions, and there is a crucial point I would like to highlight: more than 94 products have shifted from import to local manufacturing including cancer medications and dental anesthesia products

Speaking about medication quality control management ..what are the measures taken by the agency to obtain the 9001 standard?

 We are now cooperating with a certified consulting office that will walk alongside with the agency until getting the 9001 certification 9001 to control medications within a year, in order to upgrade to the third and fourth levels of control as certified by the world health organization (WHO). This would increase the price of Algerian medication, which is known for its high quality and enhance its international marketing opportunities after getting the certification.

Regarding the digitization of the sector, where has the process reached?

The agency has applied the instructions of Mr. Abdel Madjid taboun the President of the Republic , like all state institutions , indicating the importance of digitalization as a method of management Transparency. In this sense, the agency started to digitalize drug registration, so it would not be an obligation for the operator to move to the agency’s headquaters or its annexes. Instead they can submit initial processing files with only 25% of registration costs, down from the previous estimate of 100%.

In case of file recevability, the operator pays the remining regestration costs estimated at 75 per cent, with all procedures completed digitally. However, there are some documents that cannot be degitalized. Another thing that should not be overlooked, is that whitin the framework of digitization, the Agency has begun digitizing all the operators paper archives, in a way that facilitates processing tasks, and obtaining all their information since their first files deposit. It is highly predicted that the agency will launch this platform also known as the Electronic Common Technical Document “eCTD” within the current year. This will steamline operators’ files processing procedures making bureaucratic procedures easier, and enhancing access and availability of medication in the market.

I emphasize that the Agency works to overcome all obstacles facing pharmaceutical operators through activating new digital services, in addition to the online appointment services, electronic reports and inquiries to receive questions regarding the registration of human and biological medication in terms of steps to be followed.

Are there any procedures concerning leaflets, considering the continous development in medication usage ?

 The periodic review of leaflets is a really important matter. The moment  new therapeutic indications occur, they are mentioned during medication regestration process, considering its importance and its drug development, in which all producers are obliged to update them. This process is particularly crucial for patients who use the same medication over extended periods.

Concerning the joint inspections with the Ministry of Commerce, how many of them were done ?

Regarding the inspection outcome, the agency conducted 133 operations during 2023, targeting various wholesalers and distributors, aiming to address several issues including speculation, illegal storage of medications, and conditional selling. Legal actions were taken against violators. We will continue joint inspection operations if any developments arise during the current year.

The Saidal Complex along with its National Centre for bioequivalence , how would this contribute to the agency’s work ?

 The launch of the Bioequivalence Centre is a precedent in Algeria’s new history and a real gain for pharmaceutical domain in Algeria. Bioequivalence studies were costing large amount of money for operators who had to conduct them abroad, along with difficulties in transferring money abroad to cover these costs; however, currently, they can now be conducted in Algeria representing a breakthrough for medication operators whose files are pended due to the inadmissibility of the bioequivalence certificates from abroad, thereby, making it impossible to register their medication.

As a result of the centre’s launch, Algeria will gain an important financial revenues, contributing to the national economy on one hand, and facilitating procedures for the registration of medications where bioequivalence certificate is mandatory on the other hand .