Peru authorizes clinical trials through a two-agency structure: the National Institute of Health (Instituto Nacional de Salud, INS), which owns the authorization decision itself, and DIGEMID (Dirección General de Medicamentos, Insumos y Drogas — the General Directorate of Medicines, Supplies, and Drugs, a unit of the Ministry of Health, MINSA), which must issue a binding technical opinion on the investigational product’s safety and quality before INS can approve the study. Sponsors and CROs evaluating Peru as a trial site need to understand both halves of this process — they run sequentially, not in parallel, and a negative or delayed DIGEMID opinion stops the INS clock.
Who Does What: INS, OGITT/DIIS-SUDEC, and DIGEMID
INS is Peru’s national health research authority and the body that ultimately grants (or denies) permission to conduct a clinical trial. For years, the INS office responsible for evaluating and authorizing trial applications was known as OGITT — the Oficina General de Investigación y Transferencia Tecnológica (General Office of Research and Technology Transfer) — a name still widely used in sponsor-facing literature, prior INS communiqués, and legacy clinical trial registrations. Sponsors researching Peru should be aware that INS has since reorganized this function: current INS documentation and trial records refer to the Directorate of Health Research and Innovation (Dirección de Investigación e Innovación en Salud, DIIS) and its Clinical Trials Subdirectorate (Subdirección de Ensayos Clínicos, SUDEC) as the office that now authorizes and supervises trials — effectively OGITT’s successor function. Because Peruvian regulatory nomenclature has shifted more than once in recent years, sponsors should confirm the applicable office name and any procedural updates directly against current INS guidance (gob.pe/ins) or with local regulatory counsel before filing, rather than relying on any single source — including this page — as the final word on the office’s current name.
Whatever the office is called at the time of filing, its core function has stayed consistent: it receives the clinical trial application, coordinates the required external opinions (including DIGEMID’s), and issues the formal authorization once all requirements are satisfied.
DIGEMID sits outside INS entirely — it is Peru’s national medicines regulatory authority, housed within MINSA, and its role in the trial-authorization process is narrower and more technical than INS’s: DIGEMID does not evaluate the trial protocol, the ethics of the research, or the informed consent process. It evaluates the investigational product itself — its manufacturing quality, stability, and safety profile — and issues a written opinion on whether that product is acceptable to administer to human subjects in the proposed trial.
DIGEMID’s Binding Opinion: What “Binding” Actually Means
The critical procedural detail for anyone planning a Peru submission is that DIGEMID’s opinion on investigational product safety and quality is binding on INS, not merely advisory. Under Peru’s clinical trial regulation (Decreto Supremo N° 021-2017-SA), INS is required to request DIGEMID’s technical opinion as part of its evaluation, and INS cannot authorize the trial without it. In practice, this means:
- Sequencing matters. DIGEMID’s review of the investigational product dossier (manufacturing information, stability data, certificates of analysis, and related quality documentation) runs as a discrete step inside the overall INS timeline — sponsors should not assume DIGEMID review happens automatically in the background while INS works through the rest of the file.
- A DIGEMID objection stops authorization. Because the opinion is binding, INS cannot simply proceed to authorize a trial over DIGEMID’s objection on product safety/quality grounds — the sponsor must resolve DIGEMID’s concerns (typically by submitting additional product documentation) before the file can move forward.
- It is separate from ethics review. DIGEMID’s opinion addresses the product; it says nothing about the protocol’s scientific merit or the informed consent process, which are the ethics committee’s remit (below). A sponsor can have a fully DIGEMID-cleared product and still be held up on ethics committee comments, or vice versa.
The Ethics Committee (CIEI) Step Comes First
Before an application reaches INS at all, the protocol and informed consent form must be reviewed and approved by an INS-accredited Institutional Ethics Committee (Comité Institucional de Ética en Investigación, CIEI). This review is sequential, not parallel with the INS/DIGEMID track: sponsors submit to a CIEI first, obtain a signed and stamped approval of the protocol and consent materials, and only then submit the complete package — including that CIEI approval — to INS. Each accredited CIEI sets its own internal review timeline, so the ethics committee step is a variable, sponsor-influenced front end to the overall Peru timeline rather than a fixed regulatory clock. For background on how ethics committee review compares to an Institutional Review Board model more familiar to US-based sponsors, see CASRAI’s IRB vs. Ethics Committee comparison.
Submission Mechanics: Mesa de Partes Virtual and REPEC
Clinical trial applications and their supporting documentation are filed electronically through INS’s Virtual Submission Platform (Mesa de Partes Virtual, MPV), at mpv.ins.gob.pe. A complete application package typically includes:
- The CIEI-approved research protocol and informed consent form
- The clinical trial authorization application form
- A list of clinical trial supplies/investigational product inventory
- Investigational product safety and quality documentation (the basis for DIGEMID’s review)
- Payment of the applicable regulatory fee
Once authorized, every clinical trial conducted in Peru must be registered in REPEC (the Registro Peruano de Ensayos Clínicos, Peru’s national clinical trials registry), maintained by INS and publicly searchable at repec.ins.gob.pe. REPEC registration is what makes Peruvian trial records — including sponsor, investigational product, and site information — publicly visible, comparable to how ClinicalTrials.gov functions for US-registered trials. For the general principle behind these obligations, see CASRAI’s guide to clinical trial registration and reporting compliance.
Timeline: The Statutory Decision Windows
Once a complete application (including the required CIEI approval and DIGEMID’s binding opinion) is before INS, Peruvian regulation sets statutory decision windows measured in business days:
- Standard trials: INS is required to issue its authorization decision within a defined business-day window from the date the complete file is accepted — sponsors should confirm the current figure against INS’s published procedure at the time of filing, since Peru’s clinical trial framework has been amended by supreme decree and INS communiqué more than once since 2017.
- Trials involving biological products, or cases requiring referral to a technical commission: These carry a longer statutory window than the standard track, reflecting the additional technical review biologics and contested/complex cases require.
As with the office-naming question above, sponsors building a Peru timeline into a multi-country study start-up plan should treat the specific day-counts as needing confirmation against INS’s current published guidance or local counsel at the time of filing rather than as a fixed number to plan a global submission calendar around — Peru’s framework, like several other Latin American regulators’ frameworks, has been revised through supplementary decrees and communiqués rather than a single static regulation. This is the same caution CASRAI’s Argentina/ANMAT pathway guide flags for Argentina’s repeatedly-amended timeline.
Regulatory Fees
INS publishes a fee schedule (Texto Único de Procedimientos Administrativos, TUPA) covering clinical trial authorization and related procedures. Fee amounts are denominated in Peruvian Soles and are revised periodically — sponsors should confirm the current figure against INS’s published TUPA at the time of filing rather than budgeting from a figure found in older secondary sources, since administrative fee schedules are exactly the kind of detail that changes between regulatory cycles without necessarily triggering a broader procedural update.
How Peru Compares to Other Latin American Pathways
Peru’s model — a single lead health authority (INS) coordinating a mandatory, binding technical opinion from a separate national medicines regulator (DIGEMID) — is structurally similar to the split seen in several other jurisdictions where drug/device regulation and health research administration sit in separate agencies. Sponsors comparing multi-country Latin American submission strategies may also find CASRAI’s guides to Argentina’s ANMAT pathway and Canada’s Health Canada/REB framework useful for benchmarking how binding multi-agency opinions and ethics review sequencing vary across jurisdictions. For the broader regulatory-quality framework that underlies all of these national pathways, see CASRAI’s overview of Good Clinical Practice (GCP) and the ICH GCP dictionary entry.
Frequently Asked Questions
Is DIGEMID’s opinion really binding on INS, or just advisory input?
It is binding. Peru’s clinical trial regulation requires INS to obtain DIGEMID’s technical opinion on the investigational product’s safety and quality as a mandatory part of the evaluation, and INS cannot authorize a trial over an unresolved DIGEMID objection on those grounds.
What is OGITT, and does it still exist?
OGITT (Oficina General de Investigación y Transferencia Tecnológica) was the INS office historically responsible for evaluating and authorizing clinical trial applications, and the name still appears throughout older INS communiqués and sponsor literature. INS has since reorganized this function under the Directorate of Health Research and Innovation (DIIS) and its Clinical Trials Subdirectorate (SUDEC); sponsors should verify the current office name and procedure against live INS guidance before filing.
Does the ethics committee review happen before or alongside the INS/DIGEMID review?
Before. An INS-accredited Institutional Ethics Committee (CIEI) must approve the protocol and informed consent form first; that approval is then included as part of the complete package submitted to INS. The two reviews are sequential, not parallel.
Where are Peruvian clinical trials registered?
In REPEC (Registro Peruano de Ensayos Clínicos), INS’s national clinical trials registry, publicly searchable at repec.ins.gob.pe.
How are applications submitted?
Electronically, through INS’s Virtual Submission Platform (Mesa de Partes Virtual, MPV), at mpv.ins.gob.pe.
