Regulation on

Clinical Trials in

Peru

Hans Vásquez, MD

General Directorate of Drugs and

Medical Device (DIGEMID)

Ministry of Health

Lima-Peru

Sao Paulo, Oct 2013

Clinical trials in the

marketing authorization

DIGEMID is the National Regulatory Authority

General Health Law

Law N°26842

July 1997

Law N°29316

January2009

Law N°29459

Nov 2009

SupremeDecree N°016-2011

July 2011

Timeline of new regulations

• Actually, this article is changed by new

regulations.

• Past regulation (until 2009):

- Legal time to approve new medicine (including

biological product) was 7 days.

- Requirements: some information of quality and no

evidence of efficacy and safety.

General Health Law.

Article 50 in Law N°26842

General Health Law

Law N°26842

July 1997

Law N°29316

January2009

Law N°29459

Nov 2009

SupremeDecree N°016-2011

July 2011

Timeline of new regulations

• This Law was created in the framework of

“United States-Peru Trade Promotion

Agreement.”

• Modify article 50 of General Health Law and

other aspects related to commerce aspects.

• Establish new requirements to approve new

medicine.

• Is the first time, that we have requirements of

efficacy and safety.

Law N° 29316

General Health Law

Law N°26842

July 1997

Law N°29316

January2009

Law N°29459

Nov 2009

SupremeDecree N°016-2011

July 2011

Timeline of new regulations

• Law of pharmaceutical product, medical device

and sanitary products.

• Establish new requirements to approve

pharmaceutical products (including biological

products), and medical device.

• Establish principles to evaluation of quality,

efficacy and safety.

- Efficacy: supported by preclinical and clinical trials.

- Safety: supported by adverse events in clinical trials

and other information.

Law N° 29459

PharmaceuticalProducts

Medicines(chemicalsynthesis)

Herbal Medicines

Dieteticproducts

Galenicproduct

Biologicalproduct

Law N° 29459

Pharmaceutical Products

General Health Law

Law N°26842

July 1997

Law N°29316

Enero 2009

Law N°29459

Nov 2009

SupremeDecree N°016-2011

July 2011

Timeline of new regulations

• Define specific aspects of Law N° 29459.

• Describe general requirements for

pharmaceutical products and medical device.

• Describe requirements of clinical trials for

different types of pharmaceutical products.

Supreme Decree N° 016 – 2011 (1).

• Requirements of efficacy and safety for marketing

authorization:

1. Biological products: full data of preclinical and clinical studies.

2. Medicines of “List of essential medicine in Peru”: not require

clinical studies to support.

3. Medicines of reference country: “information” of safety and

efficacy.

4. Medicine with same active pharmaceutical ingredientes that

medicine from reference country and list of essential medicine,

require scientific support (clinical trials and/or bibliographic

information).

5. Medicine different to 2, 3 and 4: Full data of preclinical and

clinical studies.

6. Studies to demostrate therapeutic equivalence for copy product

based on Specific Directive.

Supreme Decree N° 016 – 2011 (2).

Clinical trials in marketing

authorization - Summary. Peru

Not requirements of clinical studies.

List of essential medicine

Information of efficacy and

safety.Reference country

Support of efficacyand safety.

Same API

Preclinical and clinical studies.

The others

Source: Law N° 29459 (2009) and DS 016-2011

Studies to demostratetherapeutic equivalence

Clinical trials authorization

Peru NIH (OGITT) is the Regulatory

Authority of clinical trials

• Supreme Decree No 017-2006-SA.

• Supreme Decree No 006-2007-SA.

Regulation

• There are 2 Authorities involved in approval process of Clinical Trials

(CT):

1. National Institute of Health (Peru-NIH).

2. National Directorate of Drugs and Medical Device (Regulatory

Authority of Medicines). DIGEMID

• Total time for to approve a CT: 40 days (working/business days).

• Only can start a CT if have:

1. Document of approval of CT (Peru NIH).

2. Document of approval the importation of investigational products

(DIGEMID).

Clinical Trial authorization

Clinical trials authorization

Peru NIH DIGEMID

Au

tho

riza

tio

n

Investigator´s Brochure + Overview of protocol

Official decisión of investigational product safety. Binding to Peru NIH (30 working days)40 days (working days)

Importation

Peru-NIH

• Reception of submission

• Official document of approval clinical trial

• Review amendments or extension.

• Coordinate GCP inspection.

DIGEMID

• Technical opinion of safety of investigational product (binding

to Peru NIH)

• Importation of investigational product

• Approval compassionate use

Responsabilities

General Information

http://www.ins.gob.pe/portal/jerarquia/2/826/informacion-para-el-publico-en-general/jer.826

Public information of clinical trials

http://www.ins.gob.pe/portal/jerarquia/2/923/resumen-de-ensayos-clinicos-en-el-peru/jer.923

Information for investigators

http://www.ins.gob.pe/portal/jerarquia/2/827/informacion-para-los-investigadores/jer.827

National Register of clinical trials

http://www.ins.gob.pe/portal/jerarquia/2/924/ingreso-al-registro-nacional-de-ensayos-clinicos/jer.924

• Link between marketing authorization (MA) of medicines

and clinical trials authorization: bioequivalence,

biosimilar, pivotal studies required by DIGEMID for MA.

• One review process of DIGEMID of investigational

product. Actually there are two.

• Improve the capacity of Ethics Committes.

Some challenges to regulation of clinical

trials

Thank you!