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Journal of Agricultural Science and Botany | Volume: 2

November 15-16, 2018 | Paris, France

Plant Science

Natural Products,Medicinal Plants and Traditional Medicines

International Conference on

Joint Event

&

Strengths and weaknesses of the herbal medicine registration system in Bahrain

Azhar H Alostad, Douglas T Steinke

and

Ellen I Schafheutle

University of Manchester, UK

T

he primary goal of a country’s Drug Regulatory Authority

(DRA) is to ensure that all products on the market are safe,

effective and meet the approved quality standards. Kuwait

however, lacks appropriate herbal medicines (HMs) regulations

causing consumer safety issues. An important part of informing

effective policy formation is to understand strengths and

weaknesses in more advanced systems. As part of a wider

research programme to inform a registration system for HMs

in Kuwait, this study aimed to highlight the main strengths

and weaknesses of the HMs registration system in Bahrain, a

country similar to Kuwait, which does not manufacture but

import all HMs and has a HM registration system. With ethics

and Bahrain DRA approval, eight face-to-face semi-structured

interviews were conducted with key officials involved in the

registration of HMs in Bahrain. Interview data were analysed

using thematic framework analysis. Participants perceived

the major strengths of the current registration system as:

having appropriate registration guidelines in place which

are continuously updated, having an increased level of

transparency by publishing registration activities and sharing

these publicly, being a trusted reference source for other

countries in the region and being an independent entity not

influenced by governmental higher powers providing full

autonomy of introducing new policies. Some of the major

perceived weaknesses of the current system were the lack in

the organisational structure and hierarchy which is causing

communication difficulties between departments, the restraint

in financial resources to invest in continuous staff training,

the significant lack of human resources causing workload and

delay in submission to deadlines, and absence of important

regulatory activities such as a pharmacovigilance system.

It is anticipated that this study will provide evidencebased

lessons for Kuwait and other countries with unsophisticated

drug regulatory systems to design effective HMs regulation.

Speaker Biography

Azhar Alostad is a pharmacist with qualifications in MPharm and MSc. She has expertise

in pharmaceutical and herbal regulations. Since her graduation, she worked as a scientific

reviewer in the Kuwaiti Drug Regulatory Authority. In 2016, she started her PhD in

Pharmacy and Pharmaceutical Sciences at the University of Manchester, United Kingdom

supervised by the coauthors Ellen Schafheutle and Douglas Steinke. Her PhD research

aims to introduce suitable guidelines for the registration of herbal medicines in Kuwait.

e:

azhar.alostad@postgrad.manchester.ac.uk

Azhar Alostad

, Plant science & Natural Medicine 2018, Volume 2

DOI: 10.4066/2591-7897-C1-003