Biosimilares y nuevas regulaciones en Perú

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Biosimilares y nuevas regulaciones en Perú
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
Timeline of new regulations
General
Health Law
Law N°
26842
Law N°
29459
July 1997
Nov 2009
Law N°
29316
January
2009
Supreme
Decree N°
016-2011
July 2011
General Health Law.
Article 50 in Law N°26842
• 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.
Timeline of new regulations
General
Health Law
Law N°
26842
Law N°
29459
July 1997
Nov 2009
Law N°
29316
January
2009
Supreme
Decree N°
016-2011
July 2011
Law N° 29316
• 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.
Timeline of new regulations
General
Health Law
Law N°
26842
Law N°
29459
July 1997
Nov 2009
Law N°
29316
January
2009
Supreme
Decree N°
016-2011
July 2011
Law N° 29459
• 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
Pharmaceutical Products
Medicines
(chemical
synthesis)
Biological
product
Herbal
Medicines
Pharmaceutical
Products
Galenic
product
Dietetic
products
Timeline of new regulations
General
Health Law
Law N°
26842
Law N°
29459
July 1997
Nov 2009
Law N°
29316
Enero 2009
Supreme
Decree N°
016-2011
July 2011
Supreme Decree N° 016 – 2011 (1).
• 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 (2).
• 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.
Clinical trials in marketing
authorization - Summary. Peru
Not requirements of
clinical studies.
Support of efficacy
and safety.
List of essential medicine
Same API
Studies to demostrate
therapeutic equivalence
Information of
efficacy and
safety.
Reference country
Source: Law N° 29459 (2009) and DS 016-2011
Preclinical and
clinical studies.
The others
Clinical trials authorization
Peru NIH (OGITT) is the Regulatory
Authority of clinical trials
Regulation
• Supreme Decree No 017-2006-SA.
• Supreme Decree No 006-2007-SA.
Clinical Trial authorization
•
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 trials authorization
Authorization
Investigator´s Brochure + Overview of protocol
Peru NIH
40 days (working days)
DIGEMID
Official decisión of investigational product safety.
Binding to Peru NIH (30 working days)
Importation
Responsabilities
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
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
Some challenges to regulation of clinical
trials
• 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.
Thank you!

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