# \[e-drug\] Relying on Stringent Drug Regulatory Authorities?
**URL:** https://talk.edrugplus.org/t/e-drug-relying-on-stringent-drug-regulatory-authorities/30413
**Category:** e-drug
**Created:** [September 1, 2008, 7:26am UTC](https://talk.edrugplus.org/t/e-drug-relying-on-stringent-drug-regulatory-authorities/30413 "2008-09-01T07:26:45Z")
**Posts on this page:** 4
**Page:** 1
### Author:  [@Rob\_Verhage2](https://talk.edrugplus.org/u/Rob_Verhage2)
#### Post date: [September 1, 2008, 7:26am UTC](https://talk.edrugplus.org/t/e-drug-relying-on-stringent-drug-regulatory-authorities/30413/1 "2008-09-01T07:26:45Z")
E-DRUG: Relying on Stringent Drug Regulatory Authorities?
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Dear E-druggers,
Suriname is a small country (population 0.5 million) in South America
with limited capacity in the public pharmaceutical sector and there are
many countries in a similar position. For some years the discussion is
regularly flaring up with regards to the policy to allow medicines on
the Suriname market.
The debate is about the sensibility and practicality to rely on
medicines that are on the market in countries with stringent Drug
Regulatory Authority instead of maintaining a Suriname DRA, of which we
know that it lacks the capacity needed to study and validate
applications with related drug files.
Countries with stringent DRA include member countries of the
Pharmaceutical Inspection Convention Scheme (PIC/S) or of the
International Conference on Harmonization (ICH). In recent years the
number of countries being member have increased considerably.
PIC/S-countries are Argentina, Australia, Austria, Belgium, Canada,
Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein,
Malaysia, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Singapore, Slovak Republic, South Africa, Spain, Sweden, Switzerland,
United Kingdom. ICH-countries are European Union member states, Japan,
United States of America.
To a certain extent, the Global Fund applies the policy of allowing the
use of medicines approved by stringent DRAs as well as medicines
pre-qualified under the WHO Prequalification project. The key question
seems to be if being a member of PIC/S or ICH does guarantee to an
acceptable level the good quality of the medicines that are allowed on
the markets in those countries and whether it is a reliable reference for
countries like Suriname to rely on. Will this be a better policy than the
current practice of relying on the (weak) capacity of local DRA to make
their own judgments based on medicines files?
I would like to hear your opinion and experience.
Regards
Rob Verhage, pharmacist
HERA Pharmaceutical Consultant
Tawajakoerastraat 4
PO Box 4002
Paramaribo
Suriname
+597 438966 or +597 8561109
verhager@cq-link.sr
Pascal Verhoeven
Pharmacist/independent consultant
Netherlands
verhoeven.pascal@gmail.com
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### Author:  [@PATRICK\_LUKULAY](https://talk.edrugplus.org/u/PATRICK_LUKULAY)
#### Post date: [September 1, 2008, 1:36pm UTC](https://talk.edrugplus.org/t/e-drug-relying-on-stringent-drug-regulatory-authorities/30413/2 "2008-09-01T13:36:19Z")
E-DRUG: Relying on Stringent Drug Regulatory Authorities? (2)
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Dear colleagues:
I'd like to weigh in on the dicussions regarding countries' reliance on stringent drug regulatory authorirites for their quality assurance needs. I could not emphasize more that quality asusurance of medicines goes beyond pre-market product registration. Countries should not outsource their responsibilities for quality assurance oversight to other bodies who, at best, could only assure that products entering the countries comply with adequate public standards.
Beyond product registration, quality assurance involves, post-market surveillance of product quality to assure that climatic conditions, storage and distribution practices do not have adverse effect on product quality. More importantly, this oversight also guards agains the penetration of counterfeit products, mimicking the original registered product. I believe that Global Fund now requires or at least suggests that countries conduct some sort of drug quality monitoring as part of the overall quality assurance framework.
Another important consideration is that unscrupulous manufacturers of pre-qualified products or products approved by stringent regulatory authorities, could change the source of raw materials to those of inferior quality and/or alter manufacturing procedures without informing the approrpiate body that quaified the product. Countries where the product end up, have the ultimate responsibily to assure product quality for the safety of their citizens. Thus, it is a bad idea for countries to outsource regulatory oversight. Countries should do all they can to develop internal capacity for regulatory and quality assurance oversight.
Regards,
Patrick Lukulay, Ph.D.
Director, United States Pharmacopeia Drug Quality and Information Program
Rockville, MD, USA
---
### Author:  [@BONFACE\_FUNDAFUNDA](https://talk.edrugplus.org/u/BONFACE_FUNDAFUNDA)
#### Post date: [September 1, 2008, 3:38pm UTC](https://talk.edrugplus.org/t/e-drug-relying-on-stringent-drug-regulatory-authorities/30413/3 "2008-09-01T15:38:33Z")
E-DRUG: Relying on Stringent Drug Regulatory Authorities? (3)
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Dear colleagues,
In 'relying on stringent DRAs' I gather that the intention is not to 'outsource' all legal/regulatory responsibilities that lie with a national DRA. I would like to think that the suggestion to use stringent DRAs has always been in respect to conducting the more costly QA/QC processes. As Patrick Lukulay (USP) points out, nations have specific local responsibilities that they can/could manage in line with what could be afforded under local budgets, human resources capacity, etc. In this respect, Suriname is not alone. If Suriname wanted to conduct QA/QC for sophisticated drug molecules, drug compounds, etc, I am sure it could: If it had the money, the expertise, etc. But would that be the best use of its limited budgets, human capacity, etc? Clearly nations can decide which way to go. The idea of using stringent DRAs is that they could be used to provide services that other nations cannot perform for whatever reason, allowing nations with limited resources to concentrate on those areas that they could afford (pharmacovigilance, etc).
In this respect, we can also refer to the efforts of the UN organisations such as WHO and UNICEF in respect to investing heavily in QA/QC on behalf of their member states (my emphasis) and programmes. These efforts ought to be understood in the same light as that of using stringent DRAs: these agencies perform upfront QA/QC work as we see in form of the WHO Pre-Qualification Project, and QA/QC tests, monitoring, etc, on for example, the long- lasting bed nets, to assure safe impregnation levels are reached all the time. That is done both as supplier due dilligence, as well as a responsible service to nations buying these products. It is assumed that they may not be in a position to perform in-country activities that could be managed by country DRAs, but may assist such countries to arrange external QA/QC lab tests at pre- qualified labs, or at stringent DRAs.
However, the concerns raised by Patrick about behaviour of certain type of supplier, ought to be taken seriously, and specially in that context of supplies beyond the registration phase. Fortunately there are sufficient suppliers of quality that take pharma business seriously, and are indeed true partners to public health.
Regards,
Bonnie
Bonface Fundafunda PhD., MBA., B.Pharm
Manager, Drug Supply Budget Line
Ministry of Health,
P.O. Box 30205,
Ndeke House,
Lusaka,
Zambia
Tel: +260 211 25 59 11
Fax: +260 211 25 14 04
Mobile: + 260 979 25 29 00
Email: bcfunda@hotmail.com\>
---
### Author:  [@Helene\_Moller1](https://talk.edrugplus.org/u/Helene_Moller1)
#### Post date: [September 3, 2008, 3:13am UTC](https://talk.edrugplus.org/t/e-drug-relying-on-stringent-drug-regulatory-authorities/30413/4 "2008-09-03T03:13:27Z")
E-DRUG: Experiences with the use of the Interagency Emergency Health Kit
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Dear Colleagues
The Department of Essential Medicines and Pharmaceutical Policies of the World Health Organisation (former WHO EDM) would like to obtain information on the use and usefulness of the Interagency Emergency Kit, in particular the version of the kit agreed to in 2006. See the WHO website at: [http://www.who.int/medicinedocs/en/d/Js13486e/#Js13486e](http://www.who.int/medicinedocs/en/d/Js13486e/#Js13486e)
Members of the e-drug community who have received / used the kit since its update are invited to share their experiences with us. As an initial informal enquiry, we are interested to know the following:
- When did you use the kit (month, year)?
- What kind of emergency situation was it used in?
- Who was the supplier of the kit?
- Which module of the kit was used (the complete kit, or if selected modules only, which ones)?
- Was the contents of the kit identical to the contents of the kit published in the WHO guideline describing the 2006 version of the kit, or was it necessary to adapt the contents to the local situation? If yes, which aspects/products were changed and for what reason?
- At what time during the emergency did you receive the kit? For example:
\* was the kit pre-positioned in anticipation of an emergency?
\* was the kit received and used in the first month after the emergency?
\* was the kit used 2 - 3 months after the emergency?
\* is/was the kit being used in a continuing emergency situation? If
yes, how often is/was it being re-supplied?
- A short description of what was useful and what was not useful when using the kit
- Any other information you wish to provide
Interested parties can write to us directly at my e-mail address: mollerh@who.int. We will summarise the experiences and share with you.
Thank you in advance
Helene Moller
Dr Helene Moller, M.Pharm, PhD
WHO Department of Essential Medicines and Pharmaceutical Policies
20 Ave Appia, Geneva 27, CH1211
Tel: (41.22) 791.1493
Fax: (41.22) 791.4167
E-mail: mollerh@who.int