At the meeting with the participation of the heads of departments of the CAE, an exchange of views took place on cooperation in the field of regulation and control of pharmaceutical products. The participants of the meeting touched upon issues related to the legislative framework, simplified registration of drugs, labeling of drugs and pricing. At the same time, the preparation of proposals for strengthening bilateral cooperation, prospects for further mutually beneficial cooperation between organizations in the field of regulation of drug control and other issues of mutual interest were discussed.

In the course of the fruitful discussion, issues related to cooperation were also touched upon and the importance of intensifying interdepartmental cooperation was emphasized.

Scientists at the University of Michigan have created a detailed atlas of ovarian cells – a map of the types of cells present in the ovaries, how they interact with each other, and how they change with age or disease.

Why is this necessary?

• Many women face premature menopause or loss of ovarian function due to cancer treatments (such as chemotherapy or radiation therapy).
• Loss of ovarian function leads not only to infertility, but also to serious hormonal problems – osteoporosis, cardiovascular disease, and a decrease in quality of life.

What’s new?

• Using modern single-cell transcriptomics (single-cell RNA-seq), they have compiled a detailed map of gene expression in ovarian cells.
• This has made it possible to understand which cells play a key role in the maturation of eggs, the synthesis of hormones and the maintenance of reproductive function.

What will this lead to?

1. The development of artificial ovaries – bioengineered structures that can replace lost functions.
2. Targeted therapy for female infertility and early menopause.
3. Personalized medicine – the ability to predict reproductive potential and correct hormonal imbalances.

In principle, we are talking about creating a “living prosthesis” that will in the future provide women with not only the ability to bear children, but also maintain normal hormonal balance.

The Chikungunya virus, which is transmitted by the bite of infected Aedes mosquitoes, causes the following symptoms:

• High fever,
• Severe joint pain,
• Skin rashes and general malaise.

The situation is worrying experts because:

• The number of cases is constantly increasing,
• There is a high risk of the virus spreading to other regions, including Southeast Asian countries and beyond Asia via international flights.

The Chinese authorities are stepping up measures:

• Mosquito extermination (disinfection),
• Strengthening sanitary control,
• Awareness campaigns are being conducted for the population.

The World Health Organization is monitoring the situation and, although it has not yet declared an international emergency, it is being seen as a “global signal,” especially in light of climate change and insect migration.

• Macular degeneration (age-related maculopathy) is the main cause of central vision loss in people over 60 years old.
• The disease affects the macula — the central part of the retina responsible for clear vision (for example, reading, driving and recognizing faces).

The role of gold nanoparticles (GNP — Gold Nanoparticles):

• The unique properties of gold on the nanoscale allow it to be used:
• as a carrier for the delivery of drugs to damaged areas of the retina;
• to protect cells from oxidative stress, which plays a key role in the development of maculodystrophy;
• it is like a photosensitizer in laser therapy.

How it works:

1. Nanoparticles are covered with bioactive molecules that purposefully bind to the affected cells of the retina.
2. After introduction into the eye (usually by injection), they release active substances locally, minimizing side effects.
3. Some methods use laser radiation that activates nanoparticles for the destruction of abnormal vessels (for example, in the wet form of maculodystrophy).

Research and results:

• In 2024-2025, several international laboratories (including in Great Britain, Japan and the USA) conducted successful preclinical tests.
• The first phases of clinical trials show:
• Slowing down degeneration;
• Improvement of contrast vision;
• Reduction of inflammation and vascular growth.

Technological advantages:

• Minimally invasive;
• High accuracy of drug delivery;
• Potential single or rare application, unlike frequent injections of other drugs (e.g., anti-VEGF).

Restrictions and challenges:

• Even more experimental level — there is no FDA or EMA approval;
• A long-term safety assessment is required: for example, how nanoparticles are removed from the body;
• The price may be high at the beginning of commercial use.

Cochlear implants are used to restore hearing in people with severe or complete hearing loss. They work by bypassing damaged areas of the inner ear and stimulating the auditory nerve with electrical impulses.

Main components:

1. External processor – receives sound signals, processes them and transmits them to the implant.
2. Implantable part – converts signals into electrical impulses and transmits them to the auditory nerve.
3. Electrode array – is located in the cochlea of ​​the inner ear and stimulates the auditory nerves.

Modern cochlear implants are equipped with powerful sound processing algorithms, allowing you to hear music and even have phone conversations.

Neural chips

Neural chips are devices integrated with the nervous system to expand cognitive capabilities, treat diseases or control external devices with the power of thought.

Applications of neural implants:

• Treatment of paralysis – chips can restore motor activity by transmitting signals from the brain to muscles or robotic prostheses.
• Treatment of epilepsy and Parkinson’s disease – deep brain stimulation using implants reduces the severity of symptoms.
• Cognitive enhancement – chips are being developed that can improve memory, information processing speed, and even connect to the Internet.

Examples of modern projects:

• Neuralink (Elon Musk) – develops brain-computer interfaces for controlling devices with the power of thought.
• Synchron – creates neural implants that do not require complex surgery, which help people with paralysis control computers.

The future of these technologies promises a significant improvement in the quality of life of people with disabilities, as well as the potential to “enhance” a healthy brain.

How do biosoluble microneedles work?

• Application to the skin: The microneedle plate is pressed against the skin.
• Penetration: The microneedles penetrate the stratum corneum of the epidermis, but do not reach the pain receptors, making the procedure painless.
• Dissolution: The needles dissolve in the skin layers, releasing the active substance.
• Absorption: The drug penetrates the bloodstream or lymphatic system, providing a therapeutic effect.

Advantages of biosoluble microneedles

• Painlessness – do not reach pain receptors.
• Ease of use – can be used without medical personnel.
• No medical waste – dissolves completely, no needle disposal.
• Increased drug stability – do not require a cold chain of storage.
• Effective drug delivery – the possibility of controlled release of active substances.

Application areas

• Vaccination (flu, COVID-19, measles, HPV, etc.).
• Insulin delivery for diabetics.
• Local administration of analgesics and anti-inflammatory drugs.
• Cosmetology (anti-aging and moisturizing products, collagen stimulation).

Development prospects

Clinical trials of new drugs are underway, the possibility of delivering DNA and RNA vaccines, biologically active substances and even stem cells are being studied. This technology can revolutionize medicine, making vaccination and drug therapy more accessible, more effective and less painful.

Let’s consider the main areas of their application:

1. Targeted drug delivery

Nanoparticles allow drugs to be delivered directly to affected cells, which increases the effectiveness of therapy and reduces side effects. For example, iron oxide nanoparticles are used for hyperthermia, in which the particles are heated in a magnetic field and cancer cells are killed.

2. Improving visualization in diagnostics

Nanomaterials are used to improve the quality of medical images. Biofunctionalized fluorescent nanoparticles can be attached to specific proteins, which allows for high-resolution visualization of tumors or other pathological changes.

3. Antibacterial properties

Silver nanoparticles are known for their antibacterial properties and are already used for medical purposes. They are effective against a wide range of microorganisms and are used to create antibacterial coatings on medical devices and implants.

4. Tissue engineering

Nanotechnology helps to regenerate damaged tissues. For example, nanostructured carbon nanotube scaffolds are used to regenerate bone tissue by providing support and stimulating the growth of new cells.

5. Development of biosensors

Nanomaterials such as nanotubes and nanowires are used to create biosensors for the detection of biomolecules. This allows for rapid and accurate diagnosis in the early stages of various diseases.

The R21/Matrix-M vaccine targets Plasmodium falciparum, the most dangerous malaria pathogen. Clinical trials have shown that it can reduce malaria incidence by more than 50% in the first year after vaccination, and a fourth dose prolongs the protective effect. When administered seasonally in combination with chemoprophylaxis, the vaccine is 75% effective.

Serum Institute of India, the world’s largest vaccine manufacturer, is set to produce over 100 million doses of R21 annually, with plans to scale up to 200 million doses per year. This will help meet the high demand for the vaccine in African countries, where malaria kills around half a million children every year.

The introduction of R21/Matrix-M into national immunization programmes has already begun. This is a significant step forward in the fight against malaria, aimed at reducing child mortality and improving public health in endemic areas.

Based on the above, a decision was made to recall the medicinal product “Rovatinex capsules No. 50”, batch number 8481C, expiration date 12/2025, belonging to the Irish marketing authorization holder “Rowa Pharmaceuticals LTD”. This means that only the medicinal product with the series 8481C, expiration date 12/2025 is recalled.

We would like to inform you that stability studies are conducted to study the shelf life of the medicinal product was carried out in special stability chambers with temperature and humidity indicators different from normal conditions. The letter states that, despite this, the manufacturer has not received any complaints regarding the drug in question.

During the meeting were discussed issues about establishing effective and constructive cooperation between Azerbaijan and the global PIC/S regulatory community, developing a roadmap to achieve compliance with PIC/S requirements, technical support and guiding the process of Azerbaijan’s application for permanent membership in PIC/S.

The purpose of the consultant’s visit is to assess the current pharmaceutical regulatory and inspection system in Azerbaijan, approve local regulations with PIC/S standards, conduct training to improve CAE’s ability to inspect and certify pharmaceutical products and the skills of inspectors and regulators. CAE staff will also be trained in conducting GMP audits and ensuring data integrity in regulatory and testing processes.

This visit underscores Azerbaijan’s commitment to adhering to international regulatory frameworks, improving healthcare standards and expanding access to global markets. It could also set the way for the Azerbaijani regulator body to join PIC/S, which will strengthen our country’s standing in the global pharmaceutical community.