New Regulation of Herbal and Traditional Medicines in Brazil

Transcrição

1 New Regulation of Herbal and Traditional Medicines in Brazil General Office of Medicines BfrM in Dialogue - TradReg 2017 Brazilian Health Regulatory gency - NVIS Regulation of Herbal and Traditional Medicinal Products Challenges of Globalisation International Symposium Bonn, September 2017

2 MISSION Protect and promote public health, by exercising health surveillance over products and services, including processes, ingredients and technologies that pose any health risks in a coordinated action with states and municipalities, according to SUS principles, to improve the quality of life of Brazilian population.

3 GGMED General Office of Medicines COOPI COREC dministrative COFR Brazilian Pharmacopoeia GESEF Herbal GMESP Homeopathic Generic Specific CPMEC COPEC and Medical gases New synthetic GRMED GEPRE CRMEC COIF CETER Biological and Radiopharmac euticals GPBIO COINC

4 Brazilian Traditional Context The use of medicinal plants and herbal medicines in healthcare Brazil - source in the culture of indigenous, frican and European peoples; WHO - encouraging the development of herbal medicines. Brazil: the context of research on medicinal plants Limitations: resources, access and infrastructure; Fragmented and disconnected research.

5 National Policy on Integrative and Complementary Practices Homeopathy, TCM/cupunture, Phytoterapy and Thermalism emphasizing primary care level; diseases prevention, promotion and recuperation of health; quality, efficacy and safety. (MOH, 2006)

6 National Policy on Medicinal Plants and Herbal Medicines In 2006 the Brazilian government approved the National Policy on Medicinal Plants and Herbal Medicines and in 2008 the National Program on Medicinal Plants and Herbal Medicines and the creation of a National Committee on Medicinal Plants and Herbal Medicines Objective To ensure the Brazilian population safe access and rational use of medicinal plants and herbal medicines, promoting the sustainable use of biodiversity, the development of the productive chain and the national industry. (MOH, 2006 & 2008)

7 Herbal Medicines and Traditional Herbal Products

8 RDC 26/2014: HM and THP registration/notification Refers to the entire process of controlling the quality of herbal drug, herbal preparation, herbal medicine (HM), traditional herbal product (THP), excipients, and the manufacturing process.

9 HM and THP HM have to present data on safety and efficacy based in non-clinical and clinical data THP have to present data to prove the human safe use for the period of at least 30 years They are for minor indications Quality control criteria - similar for HM and THP

10 RDC 26/2014 Legal documents Efficacy/safety Quality control

11 Licensing Herbal Medicine Non-clinical and clinical assessment Registration (full application); Simplified registration. Traditional Herbal Product Traditional evaluation Registration; Simplified registration; Notification.

12 Registration HM: Non-clinical and Clinical ssessment Proof of safety use (non-clinical and clinical toxicology) and of therapeutic effectiveness (non-clinical and clinical pharmacology) of the herbal medicine; Standardised extract should be used. Drafted and submitted in accordance with the sequence required by non-clinical guideline and by GCP (clinical trials), RDC 9/2015 and Resolutions 466/2012 e 251/1997.

13 Registration THP: Safety and Effectiveness Indication for minor diseases; Coherence regarding the therapeutic indications with the traditional use; Demonstration of non toxicity/no constituents with known toxicity; Oral and topic use; Demonstration of human safe use for at least 30 years.

14 Simplified registration Brazilian list IN 2/2014 EM Herbal Monographs 27 HM 16 THP

15 What can be notified? Medicines with active ingredient contained in the Herbal Medicines National Formulary of Brazilian Pharmacopoeia and Pharmacopoeias recognized by nvisa Brazilian Pharmacopoeia 5 th edition (58 herbal monographs) Herbal Medicines National Formulary of Brazilian Pharmacopoeia (83 monographs)

16 Quality Control Herbal drug Herbal preparation HM ou THP

17 Good Manufacturing Practices GMP THP HM Raw material GMP-certified (RDC 13/2013) GMP-certified (RDC 17/2010) ccording to GMP (RDC 69/2014)

18 Negative list LIST OF SPECIES THT CN NOT BE USED IN THE COMPOSITION OF THP (to be continued...)

19 Restrictions list LIST OF PLNT SPECIES WITH RESTRICTIONS FOR REGISTRTION/NOTIFICTION S HM OR THP

20 HM licensed in Brazil Combination 27 Monocomponent HM obtained from 98 medicinal plants species

21 The most licensed HM in Brazil Plant species Nº HM Mikania glomerata 25 Passiflora incarnata 22 esculus hippocastanum 20 Ginkgo biloba 20 Peumus boldus 19 Hedera helix 18 Senna alexandrina 17 Valeriana officinalis 17 Cynara scolymus 15 Plantago ovata 14 Maytenus ilicifolia 13 Panax ginseng 11 Glycine max 10 Harpagophytum procumbens 8 Hypericum perforatum 8

22 Maytenus ilicifolia Mikania glomerata Uncaria tomentosa a HM and THP available at SUS Harpagophythum procumbens Rhamnus purshiana Fitoterapia Contemporânea:: Ivone Manzali Plantago ovata Glycine max loe vera Fitoterapia Contemporânea:: Ivone Manzali Mentha x piperita Schinus terebinthifolius Fitoterapia Contemporânea:: Ivone Manzali Cynara scolymus

23 nvisa technical chambers Technical chamber of herbal medicines Brazilian Pharmacopoeia 2 committees Pharmacognosy Support herbal medicines and medicinal plants policy

24 Brazilian Pharmacopoeia Brazilian Pharmacopoeia 5 th edition (58 herbal monographs) Herbal Medicines National Phytotherapy Guide of Formulary of Brazilian Brazilian Pharmacopoeia Pharmacopoeia (83 monographs) (prescription) (28 monographs)

25 Brazilian Pharmacopoeia Public Consultations closed: CP 159/2016: Methods of Pharmacognosy - closed on ugust, 2016; CP 160 to 163/2016: 91 monographs on medicinal plants and derivatives - closed on ugust, 2016; CP 241/2016: 56 monographs on medicinal plants and derivatives of the 5 th edition - closed on November, 2016; CP 310/2017: 72 monographs for new edition of the Herbal Medicines National Formulary - closed on pril, 2017.

26 Next step Continue to seek approaches that aim at the appropriate treatment of herbal products: - adoption of the concepts of quantified, standardised and other extracts EM and Eur. Pharm.; - review RDC 26/2014, guideline and the list for simplified registration.

27 Homeopathic, nthroposophic and ntihomotoxic Medicines

28 Homeopathic, nthroposophic and ntihomotoxic Medicines RDC 26/2007 Revision in progress Registration Notification

29 Main objectives of the review Rationalization of the regularization process, making it faster. PPROPRITE CONDITIONS FOR NOTIFICTION - relatively low toxic risk medicines highly diluted, and - production process and quality control well-established. Update of technical requirements based on official references.

30 Homeopathic, nthroposophic and ntihomotoxic Medicines Public Consultations in progress: CP 373/2017. Registration, post-approval changes and notification. CP 374/2017. Therapeutic claim. CP 375/2017. Potency limits for registration and notification. CP 376/2017. Reference list for safety and effectiveness evaluation. Deadline for contributions: October 9, 2017

31 Main changes proposed Restriction of subjection to marketing authorization application: Scope reduced to higher risk medicines, considering dosage form, production process, active ingredients without traditional data and sales restriction/therapeutic claim.

32 Main changes proposed Subjection to marketing authorization application: I medicines in sterile formulations; and II medicines in any dosage form, if contain: mother tincture; new active ingredients; active ingredients on a different scale from decimal or centesimal; active ingredients at potencies outside the range described in the table (CP 375/2017).

33 Traditional Chinese Medicine RDC 21/ years monitoring the use of TCM. During this period, companies must notify the income of raw materials and health professionals the adverse effects. Observation period was extended for further 2 years RDC 152/2017.

34 Thank you for your attention! Danke für lhre ufmerksamkeit! Brazilian Health Regulatory gency NVIS SI, Trecho 5, Área Especial 57 Brasília - DF Phone: +55 (61)