Maritza Reátegui
Partner, RODRIGO, Lima, Perú
mreategui@estudiorodrigo.com

Cecilia Alarcón
Consultant, RODRIGO, Lima, Perú
calarcon@estudiorodrigo.com

Introduction: the regulatory framework for research centres in Peru

The conduct of clinical trials in Peru is governed by Supreme Decree No 021-2017-SA, Clinical Trials Regulation, and its subsequent amendment. Under this framework, every clinical study must be conducted at a research centre registered in the Peruvian Registry of Clinical Trials (REPEC) and must comply with the conditions established in the Regulation.^[1]

The Regulation defines a research centre as ‘the physical unit of the institution where one or more clinical trials are conducted, in compliance with the minimum requirements established in Annex 3 of the Regulation and others appropriate to the nature of the study’.^[2] This definition makes a distinction between the research centre, the physical and operational unit, and the broader research institution to which it belongs, which may host several such centres across different departments or specialties.

Research centres must be registered in REPEC, the registry administered by the Directorate of Research and Health Innovation (DIIS) of the INS. Registration is valid for three years and is granted following documentary review and physical verification of the centre's infrastructure against the minimum requirements of Annex 3 of the Regulation.^[3] Those requirements cover hospitalisation areas, outpatient consultation rooms, nursing stations, administrative and file management areas, investigational product storage and dispensation, sample collection and processing, laboratory facilities, and emergency response capacity. Centres without inpatient capacity are exempt from the hospitalisation unit requirement, provided they hold a formal agreement with a nearby inpatient facility. In terms of human resources, each centre must have a Principal Investigator, a research team, and administrative personnel.^[4]

Among the documentation required for trial authorisation, those directly linked to the research centre include the centre's valid registration certificate and the institutional approval from the research institution's legal representative.^[5] The INS, through DIIS, is the national authority responsible for overseeing compliance with the Regulation, authorising trials, and supervising their conduct.

REPEC Registry: scale and operational status

As of 21 February 2026, REPEC records 263 registered research centres and 5,088 cumulative authorised clinical trials since the registry's inception.^[6] These figures reflect decades of progressive institutional development in clinical research infrastructure across the country.

Most centres are active, but the breakdown reveals unused capacity:

Operational status	Number of centres	Percentage of total	Cumulative authorised trials
Active	217	82.5%	4,560
Cancelled	33	12.5%	278
Inactive for new clinical trials	12	4.6%	232
Suspended for safety reasons	1	0.4%	18
Total	263	100%	5,088

Source: REPEC Database, INS. Last entry: 21/2/2026. Own elaboration.

While 82.5 per cent of registered centres are active, a closer review reveals that 29 of the 217 active centres (13.4 per cent) have not recorded a single authorised clinical trial. This would represent a meaningful gap between registered capacity and actual research activity.

The 12 research centres classified as inactive for new clinical trials represent 4.6 per cent of the total and require a formal regularisation process before they may participate in new studies. The single centre suspended for safety reasons, representing 0.4 per cent of the total, underscores the regulatory oversight function exercised by DIIS.

Top research centres by historical activity

The five centres with the highest cumulative number of authorised clinical trials reflect the strength of Peru's leading research institutions, spanning both the public social security system (EsSalud) and the private sector:

Rank	Research centre	Institution	Cumulative authorised trials
1	Instituto Nacional de Enfermedades Neoplásicas (INEN)	Ministry of Health (MINSA)	308
2	Medical Oncology Research Unit – Hospital Nacional Edgardo Rebagliati Martins	EsSalud	173
3	Ricardo Palma Research Centre	Administradora Clínica Ricardo Palma SA	155
4	Research Unit – Hospital Nacional IV Alberto Sabogal Sologuren, Red Asistencial Sabogal	EsSalud	148
5	Research Unit – Clínica Internacional, Lima Headquarters	Clínica Internacional SA	147

Source: REPEC Excel File, INS. Last entry: 21/2/2026. Own elaboration.

The data show that the top two positions are held by oncology-specialised institutions: INEN, a public entity under MINSA, focused exclusively on neoplastic disease management, and the Medical Oncology Research Unit at Rebagliati Martins, one of EsSalud's flagship hospitals. Together, these two centres account for 481 authorised trials, representing approximately 9.5 per cent of the country's cumulative total.

This oncological strength is consistent with the broader therapeutic profile of centres registered in REPEC. A review of the EsSalud network alone, which contributes 36 registered research centres across multiple hospitals, reveals units specialising in oncology, rheumatology, infectious diseases, hematology, cardiology, pulmonology, neurology, gastroenterology, endocrinology, and mental health. The breadth of specialties covered by a single institutional network illustrates the structural weight of the social security system in Peru's clinical research landscape.

Geographic distribution and regional reach

Lima is home to Peru's most active research centres, a natural reflection of the country's concentration of specialised hospitals and academic institutions. Beyond the capital, REPEC records registered centres in Arequipa (Centro de Investigación de la Red Asistencial Arequipa, EsSalud), La Libertad (Hospital de Alta Complejidad Virgen de la Puerta), and Piura (Unidad de Investigación Oncología Clínica – Piura), evidencing a growing geographic footprint.

This expanding presence across regions strengthens the diversity of study populations and Peru's overall attractiveness as a multi-site clinical research jurisdiction.

Conclusions

Peru's clinical trial infrastructure, supported by the REPEC registry and governed by SD 021-2017-SA, presents a mature and growing research network. With 263 registered centres and over 5,000 cumulative authorised trials, the country offers a substantial foundation for clinical research. The data highlights three key observations:

• First, oncology leads Peru's clinical research output. The top two centres by historical activity are oncology-specialised, and the specialty recurs across the institutional portfolios of both public and private research centres. This reflects both therapeutic demand and the organised research infrastructure developed by INEN and EsSalud over decades.
• Second, Peru has significant room to activate its registered capacity. With 29 active centres yet to record an authorised trial, there is a clear opportunity for policymakers, sponsors, and site management organisations to expand the country's clinical trial participation.
• Third, Lima leads the network, with a growing presence of registered centres in other regions, including Arequipa, La Libertad, and Piura, reflecting the system's expanding geographic reach.

The data presented here offer a factual baseline for assessing Peru's clinical research landscape. Whether the country consolidates its position as a regional research destination will depend on how effectively its registered capacity is activated and how the regulatory framework continues to evolve.

Notes

^[1] Supreme Decree No 021-2017-SA, Clinical Trials Regulation, Art 6.

^[2] Ibid, Art 53.

^[3] Ibid, Art 54

^[4] Ibid, Annex 3, note (2).

^[5] Ibid, Art 67(b), (c).

^[6] Available at: https://repec.ins.gob.pe/maestro/centro-investigacion-busqueda-avanzada.