Pharmacology June 2025: An Industry at the Crossroads of Regulation, Bioethics, and Innovation

The world of pharmaceuticals is undergoing profound transformations. Technology, safety policies, ethical standards, and drug availability are no longer just topics for discussion, but drivers of systemic change. In June 2025, these changes became especially noticeable.

🔍 Ukraine: Pharmacists under pressure from reforms

📌 1. Transition to eCTD: on the threshold of a digital pharmaceutical bureaucracy

• From August 18, 2025, the eCTD electronic dossier system will become mandatory in Ukraine for all applicants (registration/re-registration of medicines).
• This transition ensures unification with European regulations, reduces the risk of errors, and speeds up the processing of applications.
• The platform is being implemented within the framework of the SAFEMed project (USAID) together with the SEC of the Ministry of Health.

Triggers for the institute: new documentation requirements — a field for educational programs, online courses, and practical trainings.

📌 2. Market: rapid growth against the backdrop of stagnation in packaging

• According to a study by Proxima Research, in the first 4 months of 2025, the market grew by 21% in monetary terms (UAH 64 billion), but sales volumes in terms of packages fell by 1.1%.
• The main growth is due to imported and expensive drugs, not due to the volume of treatments.

Risk: increased “price pressure” on the population, especially on socially vulnerable groups.

📌 3. Ethical promotion: Ministry of Health approved order No. 962

• Since June, Order No. 962 of the Ministry of Health has come into effect, which regulates the promotion of medicines in accordance with good practice.
• Hidden advertising, manipulative claims, and gifts to doctors are prohibited.

Important: This is a step towards building trust between the patient, doctor, and manufacturer. It is time to develop methodological recommendations for pharmacists and pharmaceutical representatives.

🌍 World: Innovation, Clinical Breakthroughs, Toxicity and AI

📌 4. Clinical innovations: the drugs of the future are already in phase III

🔹 Afimkibart (Pfizer):

• A biologic drug (antibody to TL1A) is a potential solution for ulcerative colitis and Crohn’s disease.
• Phase 3 was completed in June. It showed efficacy in patients resistant to standard therapy.

🔹 Solangepras (CVN‑424):

• A new GPR6 inverse agonist is an alternative to levodopa in Parkinson’s disease.
• Phase 3 has begun in the US. Promises fewer side effects.

🔹 DLX‑159 (Delix Therapeutics):

• A first-in-class non-hallucinogenic psychoplastogen for the treatment of anxiety and depressive symptoms.
• Considered an alternative to SSRIs and ketamine.

📌 5. FDA: betting on quantitative pharmacology

• In June, the FDA opened the Quantitative Medicine Center of Excellence, a center focused on the use of mathematical models in drug development.
• The “model-informed drug development” (MIDD) strategy should reduce the time to market for drugs and reduce the cost of research.

Forecast: by 2028, up to 40% of new drugs in the US will be evaluated through MIDD models.

📌 6. Toxicological news: pharma and ecology

• USC/UCLA have created a battery-free implant that adaptively doses analgesics without the risk of overdose.
• ScienceDaily published a study: plastic packaging of recycled drugs can release up to 80 chemical compounds, including estrogen-like toxins.
• This is a challenge for pharmaceutical logistics: the environmental friendliness of packaging must be accompanied by control of the bioactivity of materials.

📌 Conclusions

• Regulatory digitalization (eCTD) is a market-changing trend. Institutions must train new-level specialists.
• AI, models, psychoplastogens — a shift from classical “chemistry” to systems thinking. Worth more academic analysis.
• Ethics and packaging are two new political fronts in pharma: patient trust and impact on the ecosystem.