# Presentation: 516342

## VETERINARY DRUG REGULATION

**	****FACULTY OF VETERINARY MEDICINE,**
**	****P.O. Box 29053,**
**	****NAIROBI, KENYA**

**INTERNATIONAL WORKSHOP ON MNOR USE AND MINOR SPECIES (MUMS): **
**A  GLOBAL PERSPECTIVE**

**VETERINARY DRUG REGULATION**
** ****IN KENYA**

**ERIC S. MITEMA, BVM, MS, PhD**

##  USES OF DRUGS

- -  To alleviate diseases in food producing and companion animals-   Production aid in food animals(poultry, swine, etc.)
-   Regulation of these compounds has some differences with human drugs,       	in that human safety (food safety) should be taken into account.

- Review the scientific data requirements for MUMS
-   Outline some current concerns about these compounds (e.g.. risk analysis of their residues in animal products, antimicrobial resistance)

**OBJECTIVES**

**BACKGROUND**

**ANIMAL SPECIES**
-   Minor species – camels, rabbits, bees (honey), donkeys
-   Major species – cattle, sheep, goats, pigs and poultry
-   Exotic animals – game ranching, zoo animals, 				crocodiles, ostriches etc (off label usage)
-   Minor uses – These diseases are not encountered in temperate countries. In our region, however they are major diseases of economic importance
- e.g. ECF (Theileriosis), babesiosis, anaplamosis, trypanosomosis

- Specific treatments
- Theileriosis – parvaquone, buparvaquone (approved)
- Babesiosis – diminazene, imidocarb,
- Anaplasmosis- imidocarb, OTC
- Data requirements
- CAP 344 of PPB (1982) – all products with therapeutic claim on specific diseases in livestock and companion animals must be registered.
- Data requirements is the same for all drugs.
- However some drugs (orphan drugs) may be administratively approved without going through rigorous review due to limited economic  returns

## Ensure pharmaceutical quality

- Ensure proper distribution and storage
- Assess efficacy data
- Assess safety -target animal		-human consumer
- - Environmental safety
- Ensure prudent use (overuse and misuse) for instance antimicrobials.

**NEED FOR REGULATION**

## QUALITY CONTROL AND 

-   There is a need for harmonization of GMP. In some countries 	(USA, EU and Japan) attempts are underway.
-   National laws should ensure good quality assurance during 	manufacture.

**QUALITY CONTROL AND **
**DISTRIBUTION REQUIMENTS**

## QUALITY CONTROL AND DISTRIBUTION REQUIMENTS Cont’d

-   Mutual recognition of manufacturing/import authorization 	should  be encouraged between competent and regional member 	countries.
-   Raw materials should be sourced from approved and reputable outlets.
-   Distribution of these compounds should conform with National and 	International law.
-   Veterinarians should continue to prescribe to ensure proper use.
-   OIE code of practice requires that all veterinary drugs are registered 	with respective authorities.

## EFFICACY ASSESSMENT

-   For new molecules data should be generated by sponsors (pre-clinical and clinical efficacy studies)
-   For generic compounds - bioequivalence studies should be done. Clinical efficacy data can substitute bioequivalence studies in some cases
-  Studies should be done according to good clinical practice veterinary (GCPV)
-   GCPV requires:	- qualified/competent investigator, proposal in place, data auditing, 	   documentation and verification of clinical trials	- High level of professionalism, including the welfare of trial 		   animals.

**EFFICACY ASSESSMENT**

## SAFETY ASSESSMENT

-   Includes all toxicological studies for new compounds (acute, sub-acute or chronic studies)
-   Other long-term studies - Carcinogenic, teratogenic, mutagenic/genotoxic, multigenerational and developmental reproductive toxicity studies, etc.
-   Adequate pharmacological studies should be included
-    Laboratory animals (mice, rats, guinea pigs, rabbits, etc) are employed

**SAFETY ASSESSMENT**

## Antimicrobials- safety assessment

-   Risk-based evaluation for all antimicrobials used in food animals should be conducted for their potential in human health
-   Regulatory authorities should ensure that surveillance on the potential of antimicrobial resistance is monitored (zoonotic bacteria - *E.Coli, Salmonella spp,Campylobacter spp*)

##   No - observed effect levels (NOEL) should be established from either toxicological or microbiological (antimicrobials) end point

-   Acceptable daily intake (ADI) should be derived from the NOEL applying a safety of X100
-  ADI           MRL
-   MRL is apportioned to the various edible tissues (fat, liver, kidney, muscle or milk, eggs)
-   Regulatory authorities should ensure that all compounds for food producing animals have withdrawal periods before sale/slaughter fixed.

- SAFETY ASSESSMENT cont’d

## ENVIRONMENTAL SAFETY

-   Potential environmental impacts associated with the commercial use of drugs and feed additives
-   Environmental toxicology data supplied by sponsors should cover both the recommended use and safety precautions to minimise potential risk in the environment
-   Data requirements – e.g.  oral ivermectins

**ENVIRONMENTAL SAFETY**

## CONCLUSIONS / RECOMMENDATIONS

-    Surveillance for the potential for antimicrobial resistance in man and livestock should be underway for all antibiotics being used n food animals
-    Regular interactions through seminars, workshops should be encouraged
-    Harmonised regulation for these compounds should be undertaken in a global perspective and within the regions
-    Competent regulatory authorities should offer training opportunities and sabbaticals for experts  from the developing countries

**CONCLUSIONS / RECOMMENDATIONS**