New challenges on regulation of biotechnological products in peru

Transcription

1 New challenges on regulation of biotechnological products in peru Hans Vásquez, MD, MPH Senior Clinical Reviewer Team of Biological Product General Directorate of Drugs and Medical Device Ministry of Health Lima-Peru WCBP 2014, January Washington DC USA

2 The view expressed in this presentation are not necessarily of the General Directorate and Medical Device (DIGEMID).

3

4 Timeline of new regulations General Health Law Law N July 1997 Law N Nov 2009 Directive of Biotechnologi cal/biosimilar Products Law N January 2009 Supreme Decree N July 2011 *

5 General Health Law (GHL). Article 50 in Law N The article 50 of GHL (until 2009) said that: - Legal time to approve new medicine (including biological product) was 7 days. - Requirements: some information of quality, no evidence of efficacy and safety.

6 Timeline of new regulations General Health Law Law N July 1997 Law N Nov 2009 Directive of Biotechnologi cal/biosimilar Products Law N January 2009 Supreme Decree N July 2011 *

7 Law N January 2009 Modify article 50 of General Health Law (GHL). Establish new requirements to approve new medicine. Is the first time, that we have requirements of efficacy and safety.

8 Timeline of new regulations General Health Law Law N July 1997 Law N Nov 2009 Directive of Biotechnologi calproducts Law N Enero 2009 Supreme Decree N July 2011 *

9 Law N November 2009 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 evaluate quality, efficacy and safety.

10 Law N November 2009 Pharmaceutical Products Medicines (chemical synthesis) Biological product Pharmaceutical Products Herbal Medicines Galenic product Dietetic products

11 Timeline of new regulations General Health Law Law N July 1997 Law N Nov 2009 Directive of Biotechnologi cal/biosimilar Products Law N January 2009 Supreme Decree N July 2011 *

12 Supreme Decree N Chapter V. Biological product Define specific aspects of Law N Describe general requirements for biological products: full data of quality, efficacy and safety. Biological products: including vaccines, allergens, antigens, hormones, cytokines, plasma derivates, immunoglobulins, immune sera, antibodyes, product of fermentation (including products derived from rdna) and others. Describe general requirements to submit and evaluate similar biological product: based in recomendation of WHO.

13 Timeline of new regulations General Health Law Law N July 1997 Law N Nov 2009 Draft Directive of Biotechnologica l Products Law N January 2009 Supreme Decree N July 2011 *

14 Directive of Biotechnological product Draft (1) Published in February 2013 for public consultation. Contain specific aspects of requirements to approve biotechnological product (including similar biotechnological product), based in general requirements for biological product (approved in Peru in 2011). This document is based in recomendation of WHO. Also, is based on ICH guidelines and guidelines of regulators with more experience (EMA, Health Canada, FDA and others).

15 Directive of Biotechnological product Draft (2) The Directive received suggestion of different institution: global and national pharmaceutical companies, academia, regional and global nonprofit institutions, and others. In 2013, DIGEMID had meetings with different groups (global and national industry, and academia) to explain Biotech Directive.

16 Directive of Biotechnological product Draft (3). General structure General aspects: definition, general considerations to approve and review biotech product. Glossary Quality, preclinical and clinical requirements for biotech product. Requirements for similar biotech product.

17 Some changes in review process (1) New regulations introduce changes not only in our regulation; also, the reviewers need adaptation of changes. Since 2012, DIGEMID conform a Team In charge of review biological product. Actually the group have 7 reviewers (CMC and clinical reviewers)

18 Some changes in review process Team of Biological Product is working new specific regulation of vaccine, derived plasma, biotech product and others Directives. Not only DIGEMID need adaption to new requirements; also, the industry.

19 Perspectives (1) Approval of Directives for biotech product in 2014 (and vaccine and plasma-derived directives). Develop specific Directives in some aspects of quality in biological products (stability, validation and others). Develop specific requirements for other biological products

20 Perspectives (2) Insert good review practice, procedures and templates in the review process. More transparency, predictibility, efficiency.. More sharing with other regulatory authorities (NRA), specially with NRA with more experience in the world and in our region.

21 International Perspectives (1) Pan American Network for Regulatory Harmonization (PANDRH): Opportunity to share experiences with other countries, that have similar challenges; also, an opportuntiy to learn of other NRA with more experience (FDA, Health Canada, ANVISA and others) and contribute with our little experience building new regulations.

22 International Perspectives (2) Peru is main member of Working Group of Biotech Product in PANDRH. We have participated in workshops, virtual meetings, sharing experience with countries that start to develop new regulations in biotech product in our region and supporting spanish version of WHO guideline on biosimilars.

23 International Perspectives (3) Asia-Pacific Economic Cooperation (APEC): DIGEMID participate in initiatives related to regulatory convergence. We are participating in working group of biotech product, multiregional clinical trials, good review practice and others.

24 Thank you! Muchas gracias