dietary supplements regulations worldwide

[Blog] Regulations` mosaic: A look at dietary supplements requirements

Dietary supplements are products containing concentrated sources of nutrients or other substances such as vitamins, minerals, products of animal origin, amino acids, metabolites, etc.             The definition of these products is different according to the country. In China they are called Health food, in the EU –...

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Changes in the codification of medicinal products in France

[Blog] Changes in the codification of medicinal products in France

  In this article we will give some clarifications on the use of global vs national standards for the codification of medicinal products to implement the EU Falsified Medicine Directive (EU FMD) in France.             Background   In 2019, GS1 adopted rules for ensuring unique identification and integrity in its...

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kazakhstan traceability requirements

[Blog] Action plan for labelling and traceability of medicines in Kazakhstan

  In July 2023 the Republic of Kazakhstan announced a comprehensive strategy for introducing labeling and traceability of medicines.             The aim is to enhance transparency, accountability, and efficiency in the pharmaceutical sector. The plan uses a series of organized actions, including changing rules, sharing data, and giving...

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track and trace compliance africa

[Blog] Track and Trace Compliance Landscape in Africa (part 2)

Introducing the second article of the series on Africa's Track and Trace Compliance landscape. In this paper we will look through the Track and trace systems in Zambia, Botswana and South Africa.         Zambia   In late October 2021, the Zambia Medicines Regulatory Authority (ZAMRA) published a draft Guideline...

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Serialization deadline in Jordan expanded by JFDA

[Blog] Serialization deadline in Jordan expanded by JFDA

  JFDA extended the implementation deadline for DataMatrix and serialization on secondary packaging on regulated pharmaceutical products until 30 September 2023.             Journey towards traceability implementation   Jordan announced the implementation of pharma serialization in 2017. The first phase included a transition period during which 2D DataMatrix codes were allowed...

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BPOM announced the e-Labeling Pilot in Indonesia

[Blog] BPOM announced the e-Labeling Pilot in Indonesia

The Indonesian Food and Drug Monitoring Agency (BPOM) has launched an initiative called the e-Labeling Pilot Project which certainly will make a significant impact in the healthcare industry.     Current labelling and packaging regulations     Pharmaceutical products must comply with specific labelling and packaging requirements, including information on indications,...

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[Blog] MDR – Significant changes you want to know

In May 2023 Medical Device Coordination Group (MDCG) approved new changes to the design or intended purpose of medical devices. Some of them are considered significant while others are non-significant. Products with certificates issued under the old EU directives can stay on the market during...

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track and trace compliance africa

[Blog] Track and Trace Compliance Landscape in Africa (part 1)

    Countries in the region of Sub-Saharan Africa are working on the alignment of GS1 standards, aiming to enhance the pharma traceability.           This is the first article of the forthcoming series about the Track and Trace Compliance landscape in Africa. A while ago, Africa's countries started their...

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cloud service in pharma

[Blog] Value-added technologies for Intelligent Pharma Supply chains

    The Pharma industry requires limitless technologies with a wide range of services as are cloud computing services and Microsoft Azure             Pharmaceuticals are one of the most dynamic sectors because of the constant change and evolution. While customer demands are a primary influence and priority, the pharma...

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pharma track and trace in north america

[Blog] Track and Trace Compliance Landscape in North America

USA, Canada and Mexico – three completely different journeys towards track and trace compliance               North America continues to be the largest pharmaceutical market in the world. Nevertheless, on the territory of the continent is the USA which has captured a dominant share of the pharma market...

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pharma companies inflationary management

[Blog] How pharma companies manage the IT spending in an inflationary environment

  SaaS, infrastructure software, IaaS, and PaaS are the technology investment areas where everyone most expects inflation/currency fluctuations to affect budget decisions.             During challenging economic times, CIOs and CFOs tend to scrutinize their budgets, especially the largest and fastest-growing parts which usually are related to on-premises solutions...

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cloud solution evolution

[Blog] From on-premises and cloud to hybrid solution model

Discover the main differences between the solution technologies, enhancing your business process and data exchange           Today`s technologies provide supply chain participants with a wide range of solution options. Each enterprise could choose the best type for them depending on its needs, priority functionalities, financial capabilities, industrial...

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chatgpt impact pharma

[Blog] ChatGPT`s impact on the Pharma industry

  Using ChatGPT, AI steps further into the Pharmaceutical activity   No matter how frequently you are use your phone and laptop or what your source of information is, you undoubtedly heard the term – ChatGPT. That is not just another fancy word that will be a trend...

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