On 13 February 2026, the International Council for Harmonisation (ICH) published the “Sakura Bloom R2” mock example, developed by the M4Q(R2) Expert Working Group to illustrate the revised structure and presentation of CTD Quality Modules 2.3 and 3 under the draft ICH M4Q(R2) guideline. While explicitly non binding and intended for illustration purposes only, the example offers a concrete glimpse into how quality dossiers are expected to evolve in the coming years.

The Italian Medicines Agency (AIFA) has introduced a new framework to streamline price and reimbursement (P&R) negotiations, aiming to shorten timelines, accelerate patient access, and focus regulatory effort on high complexity dossiers.

The Medical Device Coordination Group (MDCG) has published a Guidance MDCG 2025-10 on post-market surveillance (PMS) for medical devices and in vitro diagnostic medical devices, providing comprehensive clarification on expectations under the MDR (EU) 2017/745 and IVDR (EU) 2017/746.

The Italian Medicines Agency (AIFA) has issued updated guidelines for the classification of non-prescription medicines (SOP and OTC), introducing clearer criteria aligned with the European framework and replacing the previous 1997 circular.

The European Medicines Agency has released draft guidance on the conduct of clinical trials during public health emergencies, outlining a more risk-proportionate and flexible framework for both new and ongoing studies. The document emphasizes that participant rights, safety and data integrity must remain central, even when urgent public health needs require faster regulatory action.

The European Medicines Agency (EMA) has issued a new Good Pharmacovigilance Practices (GVP) Product or Population Specific Considerations III on the use of medicines in pregnant and breast-feeding women, and children exposed in utero or via breast milk, in effect since February 9th, 2026.

In the pharmaceutical sector, effective promotion relies on structured plans that combine scientific content, compliant channels, and consistent brand positioning.

Purpose Hypoparathyroidism (HPT) is an endocrine disease caused by insufficient levels of parathyroid hormone (PTH).
PTH is the primary regulator of the calcium/phosphate balance, acting directly on bone and kidney, and indirectly on the
intestine. Regarding the epidemiology of chronic HPT, there are limited data in Italy. This study aimed to establish incidence
and prevalence of chronic HPT in Italy.
Methods A systematic literature review was conducted to identify the current knowledge regarding the epidemiology of
chronic HPT in Italy, and a random effect meta-analysis was performed to estimate the pooled incidence. A subgroup analysis
of non-surgical and postsurgical HPT estimates for patients was also conducted.
Results We identified 4 studies eligible for inclusion reporting data from 15,412 patients with HPT. Considering a thyroidectomy
rate of 57 per 100,000 and the incidence of post-surgical chronic HPT (≥ 6 months after surgery) at 1.2% (95% CI:
0.7%-1.8%), the number of incident post-surgical chronic HPT was estimated in 353 cases. Based on a mean time with
chronic HPT after diagnosis of 17.4 years, a total of 6,142 prevalent post-surgical chronic HPT patients has been estimated
for Italy. Findings from this analysis showed 4,383 prevalent non-surgical chronic HPT cases in Italy. The prevalence of
chronic HPT, both surgical and non-surgical, in the adult population in Italy has been estimated to be 10,524 cases.
Conclusion This study provides a current estimate of the prevalence and incidence of chronic HPT in Italy. In this analysis,
postsurgical chronic HPT accounted for the majority of prevalent cases. Epidemiological studies with appropriate study
design are necessary to provide a validated estimation of the prevalence and incidence of HPT in Italy.

AIFA has released Version 4.0 of its Q&A document on EU Regulation 536/2014, providing essential operational clarifications for conducting clinical trials in Italy.