REPORT OF BIOEQUIVALENCE STUDIES – EXTENSION OF DEADLINE
By means of Ministerial Resolution No. 098-2024/MINSA, the deadline established in paragraph b) of Article 1 of Ministerial Resolution No. 195-2022/MINSA, referring to the submission of the bioequivalence study report for drugs that require bioequivalence studies (in vivo), was extended for twenty-four (24) months, counted as of its expiration.
Therefore, the new deadline to submit the bioequivalence study would expire on March 12, 2025.
BPM CERTIFICATION – FOREIGN LABORATORIES
By means of Ministerial Resolutions No. 96 and 97 -2024/MINSA, Digemid officials were authorized to travel to Mexico and Chile to inspect laboratories in order to grant the GMP certification.
INS
CLINICAL TRIALS – PROJECT THAT REGULATES THE DISPENSING UNIT
Ministerial Resolution No. 058-2024/MINSA published the draft Technical Health Standard that regulates the Dispensing Unit for Clinical Trials.
Article 92 of the Clinical Trials Regulations establishes that the dispensing of investigational products must be done through a Clinical Trials Dispensing Unit under the Pharmacy Service or Department of the research institution where the clinical trial is being conducted.
This draft Technical Standard regulates the processes of reception, storage, conservation, preparation, repackaging, dispensing, inventory and return of investigational products in health establishments that are research institutions where duly authorized clinical trials are conducted.
CLINICAL TRIALS IN PERU – STATISTICS
According to the INS in 2023, 37 clinical trials were authorized in which 1779 subjects are expected to participate regarding the following diseases: lung cancer, stomach cancer, breast cancer, advanced tumors, rare and orphan diseases, recurrent multiple sclerosis, lupus, etc.
This number of authorizations constitutes an increase of 60% compared to the year 2022.
MINSA
IMPLEMENTATION OF “FARMAMINSA” PUBLIC BÓTICAS
Ministerial Resolution No. 100-2024/MINSA approved Administrative Directive No. 351-MINSA/DIGEMID-2024, Administrative Directive for the implementation of the Public Drugstores “FARMAMINSA”.
This Directive provides that the Ministry of Health must implement public pharmacies, through the DIRIS/DIRESA/GERESA. The pharmacies will be called FARMAMINSA and will offer PNUME medicines and PNUDME medical devices. The DIRIS/DIRESA/GERESA will supply these pharmacies.
DIABETES
Ministerial Resolution No. 115-2024/MINSA approved the Technical Guide: Clinical Practice Guideline for the diagnosis and treatment of Type 1 Diabetes Mellitus in children, adolescents and adults. This contains updated criteria for the diagnosis, treatment and follow-up of Type 1 Diabetes Mellitus.
Likewise, Ministerial Resolution No. 114-2024/MINSA approved the new Technical Health Standard for the Epidemiological Surveillance of Diabetes to standardize the process of epidemiological surveillance of this disease in all health facilities, including the private sector. It provides that epidemiological surveillance of diabetes should be carried out by level I-4 and I-3 health facilities where people with diabetes are diagnosed and treated. It also establishes the duties of the professional responsible for epidemiological surveillance in the facility.
MODIFIED THE SANITARY EMERGENCY REGULATION
Supreme Decree No. 003-2024-SA amended the Regulations of Legislative Decree No. 1156 Legislative Decree that establishes measures to guarantee the public health service in cases of high risk or damage to the health and life of the population.
The definition of damage to health was broadened by adding the assumption of “sudden interruption of the provision of health services” and “adverse effects on public health resulting from the occurrence of an event”. Before the amendment, only “consequence of outbreaks, epidemics or pandemics” was considered as damage to health.
These new assumptions in the definition would be configured as new possibilities for a health emergency to be constituted only when the measures implemented to control them are not sufficient, and this has the consequence of affecting the continuity of health care services.
THE REGULATION OF THE FOOD AND NUTRITIONAL SECURITY LAW WAS APPROVED
By means of Supreme Decree No. 003-2024-MIDAGRI, the Regulation of Law No. 31315, Food and Nutritional Security Law, was approved.
This Regulation complements and makes operational the legal framework established in Law No. 31315, for the implementation of public policies on food and nutritional security. In other words, it details the guidelines established in the Law and assigns competencies to the ministries involved in the promotion of food and nutritional security. It also adds new guidelines referring to the promotion of sustainable food systems.
It also introduces into Peruvian law the concept of “food emergency”, which is accessory to other types of emergencies.
In the event of a food emergency declaration, MIDAGRI and the Ministry of Production adopt measures to contribute to minimize the risk of affecting food availability, with special emphasis on feeding the population living in poverty and extreme poverty, and children, adolescents, the elderly and people with disabilities.
