[e-drug] Medicine registration databases

e-drug
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E-DRUG: Medicine registration databases
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[mSupply has now developed a comprehensive software program that can do everything Pascal mentions in the way of dossier records, registration of products and licenses of companies and premises and alerting for annual fees where relevant etc. I am not sure about linking with QC labs but I am sure that is possible. BS]

Dear E-druggers,

SIAMED, WHO/PAHOs medicine registration database was developed with MSH in
1998, in FoxPro. Does it still exist and work?
Is SIAMED what NRAs still use in general, also to communicate with each
other in regions? Have other open source software systems been developed
and put to use that e.g. allow online applications, importation/licenses,
mobile linkage for real time data to and from inspectors scanning/screening
medicines samples in health facilities, and at borders, linking data with
QC labs' LIMS data on testing?

thanks in advance for information/experiences,
Pascal

with kind regards
Pascal Verhoeven
MPH/pharmacist
June-October 2018 ADB consultant for ABEC pilot
Kazakhstan/Kyrgyz Republic
Pascal Verhoeven <verhoeven.pascal@gmail.com>

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E-DRUG: Medicine registration databases (2)
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Dear Pascal,
Now not only registration but complete Integrated Regulatory Information Management System( IRIMS) is Launched bY USP GPH with financial support of Global Fund Under GFTAM HSS grant In Pakistan. This soft toll is developed by USP GPH experts for Drug Regulatory Authority Of Pakistan( DRAP) for details you can contact Mr Waqas Ahmed Regulatory Specialist USP Pakistan(waqas.ahmed@usp.org)This fully automated IRIMS soft Tool have all regulatory information on one dashboard.

Khalid Saeed Bukhari,
Chief of Party,
USAID PQM, USP, Pakistan.
ssb@usp.org
Dr Khalid Saeed Bukhari <skhs77@gmail.com>

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E-DRUG: Medicine registration databases (3)
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Dear Pascal,

An online version of SIAMED (now called IRIMS) has been developed and
implemented in 3 Latin American countries and most recently in Myanmar.
The system used by Myanmar FDA includes 3 main components: drug
registration, inspectorate and QC lab. Myanmar FDA inspectors use tablet
computers during field work to check registration validity, see product
images, and upload inspection reports and pictures of inspected sites.
Monitoring of importation is there but not yet implemented due to the
time required to operationalize connections with other 2 concerned
institutions outside MOH.

IRIMS uses open-source software (postgre as database, php and javascript
as programming language). There are no licences to pay and the only
maintenance cost required is renting a dedicated web server in an
appropriate data centre (depending on data and number of simultaneous
users, this ranges from USD1,700 to USD 7,000 per year). Time lines for
implementation in Myanmar: Aug 2017 assessment of adaptations required;
October-December 2017 finalization of drug registration module, training
of applicants (company staff submitting applications), training of FDA
staff; Feb 2018 FDA issues new regulation to accept drug registration
applications only via online system; May 2018 Inspectorate module
adopted, tablets procured and inspectors trained; June 2018 QC lab
started implementation, adaptations still ongoing.

The cost of implementation in Myanmar has been about USD150,000
including everything: consultants, IT development, travel, training,
provision of 3 desktop computers + 38 10-inches tablet computers,
2-years rental of dedicated web server, IT maintenance and adaptations
guaranteed until June 2019.

Myanmar implementation resulted from collaboration between WHO-SEARO and
ADB.

I don't know anything about the setup of the regulatory authorities of
Kazakhstan or Kirghiz Republic and therefore cannot estimate what
adaptations would be necessary for its possible use in these situations.

I have not seen mSupply (mentioned by BS) and I don't know where it is
implemented, so I cannot comment on this.

Kind regards

Valerio Reggi
Valerio <vareggi@gmail.com>

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E-DRUG: Medicine registration databases (4)
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Thanks Valerio Reggi for the reply
that sounds great. An online integrated information management system for
DRAs is what i was looking for. Most of the older SIAMED packages in FoxPro
if still working are - i imagine - running on a stand alone, older PC
somewhere in an central office with little interoperability. Since then
countries have been developing local IT solutions from what i have seen to
link central databases to data collection tools, with different
results/costs. Maybe we can expect more feedback from countries on what is
working.

Where can the IRIMS OS software be accessed (i didn't get relevant result
looking for 'IRIMS' on the WHO website not internet). Is there a link to
the software that you could share for interested readers to explore? Does
it have multi-language functionality? Looking forward to hearing more on
IRIMS.

ps: this is not for kazakhstan, perhaps kyrgyzstan; i was though looking at
solutions such as IRIMS or mSupply (referred to above by moderator) as an
option for the MOH in Timor Leste.

thanks, best regards
pascal verhoeven
Pascal Verhoeven <verhoeven.pascal@gmail.com>

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E-DRUG: Medicine registration databases (5)
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Dear Pascal,

You will not be able to find much about it browsing the web. Two main
reasons: a) it is complex and one needs some guidance to understand how
it works; b) creating a demo version takes time and money (both usually
out of stock). If you are still with ADB and happen to pass by HQ 18
Nov-3 Dec, please let me know and we could try and meet to look at it
together.

Like SIAMED, IRIMS can work in any language.

If you have Timor Leste in mind and - if it seems - they are willing to
align with ASEAN drug registration requirements/guidelines, then IRIMS
would fit well because is already built around ASEAN CTD (common
technical dossier).

Kind regards

Valerio

PS - I have just googled irims myanmar and got this
Valerio <vareggi@gmail.com>

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E-DRUG: Medicine registration databases (6)
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Hello,

MSH under the USAID-funded Systems for Improved Access to Pharmaceutical
and Services (SIAPS) Program developed and implemented in a number of
countries an online medicines registration system, Pharmadex, that may meet
some of the requirements of Pascal. Pharmadex is a web-based tool that
helps streamline and track medicines registration for a national drug
regulatory authority by

   - Recording and organizing information on suppliers and products
   - Tracking product applications in the registration process
   - Analyzing and comparing suppliers and products
   - Tracking critical information for decision-making, such as costs,
   usage, and safety

Features

   - Online application system: facilitates standardized formatting,
   storage, cataloguing, and retrieval of documents
   - Multiple database storage: supports and coordinates databases across
   several regulatory units
   - Licensing and inspection transparency: generates and allows easy
   sharing of licenses, inspection reports, and enforcement updates
   - Product lifecycle management: enables tracking of promotional
   activities, safety monitoring, and approval history for products
   - Round-the-clock registration: allows timely, convenient access to
   national register of products
   - International standards access: provides access to international
   standard terminology databases and dictionaries
   - Monitoring and evaluation: enables overview of aggregate data and
   management information
   - Adjustable modules and user privileges: allows modules to be added or
   removed and user access to be restricted

Pharmadex is currently in use in Bangladesh, Ethiopia, Mozambique, and
Namibia.

To view a demo version of the site, visit
http://pharmadex.msh.org
and
click the Login link. Follow the instructions on the screen.

You may also access the open source code for Pharmadex on Github at
https://github.com/MSH/Pharmadex

Best Regards
kn

Francis Aboagye-Nyame,
Program Director,
Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program
Management Sciences for Health
4301 N. Fairfax Dr. Suite 400, Arlington, VA 22203
USA
Aboagye-Nyame, Francis <fnyame@msh.org>