Biosimilares y nuevas regulaciones en Perú
Transcription
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!