definition of THMP
- herbal or traditional medicine is a medical product, not a food or dietary supplement or cosmetic product
- contains 1 or more herbal substance as active ingredients
- active ingredients are not synthetic
what are not considered THMP
- drug products (chemically synthesised)
- biologicals and biotech derived medicinal products
- food, dietary, nutritional supplement
- cosmetic products
- medical devices
ICH product quality guidelines
- product quality and performance can be improved by focusing upstream on pharmaceutical development (Quality of design)
- regulators and manu recognise capability of sci and tec (eg. PAT, QBD to improve quality)
current regulatory status for THMP
- lack of harmonised GMP standards for THMP
- minimal product qualityu requirements
- limits of micro organiusm in finished THMP
- limits of toxic heavy metals in finished THMP - product quality attributes which are not mandatory
whart are product quality that are not mandatory for THMP
- control of herbal active ingredients (identification and assay)
- control of other starting material (water, preservatives, excipients)
- control of container-closure systems
- stability (shelf life) testing and process validation
- control of herbaL contaminants (pesticides, fumigants)
challenges in regulating THMP
- harmonisation of GMP standard for THMP
- harmonisation of quality standard for THMP
- combating adulterated THMP
- leveling up of cottage THMP industry
- implementation of GACP
harmonisation of GMP standard for THMP
52 PIC/S participating authorities with effect from 1/1/18 including
1. EU members
2. australia, NZ, canada, USA
3. SG, MY, Indo, Thai, KR, Jap, TW, HK
4. argentina, South africa
and more authorities are applying to join PIC/s, making it a good starting point for global harmonisation of GMP s standard
harmonisation of quality standard for THMP
safety and efficacy may be indirectly inferred from historical use, while quality might be independent
- if herbs are processed, packed and presented as pharmaceutical dosage forms, then established quality requirements for pharmaceutical products should apply to THMPs
contents of EMA document
- QC of herbal active ingredient
- QC of other starting material (including water)
- control of container-closure systems
- stability (shelf life) testing
- control of herbal contaminants, including pesticides, fumigants, heavy metals, microbial limits
why control of water quality is important
- main starting material in oral liquid THMP has to meet pharmaceutical quality standard
- quality of feed water is variable depending on source of water, and seasonal variation
- contains chemical and mineral impurities which affects stability profile and quality of THMP in liquid dosage forms
- contains microbiological impurities: good potential medium for microbial growth will affect product stability or quality and pose health risk
properties in water we need to compare
- pH
- heavy metals
- total organic carbon TOC
- Oxidisable substance
- Conductivity
- microbial limit
profile of manu of adulterate THMP
- unscrupulous manu in backyard facilities with improper equipment
- with deliberate intent to cheat (criminal in nature)
- cause acute toxicity to patients
- adulterants often present in large amounts
suspected adulterants for slimming
- fenfluramine
- thyroxine
- sibutramine and analogues
suspected adulterants for baldness
- minoxidil
suspected adulterants for arthritis
- steroids
2. NSAIDs
suspected adulterants for fever, cold, flu, typhoid
- paracet
- aminopyrine
- chlorpheniramine
suspected adulterants for epilepsy
phenytoin
suspected adulterants for erectile dysfunction
- sildenafil
2. tadalafil and analogues
what are analogues
synthesised drugs to circumvent drug laws, usually attachment of additional atoms, side chains or other functional group
combating adulterated THMP
- educating consumers and public
- increased industry vigilance
- exchange of info and alerts amongst regulators (internationally)
- sharing of test methods and reference standards for testing adulterants, including new analogues
- inspectors: robust GMP/GDP audit and tight chain control
leveling up the THMP industry
balancing interest of stakeholders
- fast market access: public safety/quality issues
- trade commercial interest: societal interest
- national considerations: globalisation and harmonisation
- THMP regulation: pharmaceutical regulation
