In the 1990s, the MedDRA (Medical Dictionary for Regulatory Activities) terminology was created to facilitate the international exchange of medical device regulatory information. The WHODrug is an international classification of medicines developed by the World Health Organization (WHO) and used in about 150 countries.
Together, these initiatives help unify pharmacovigilance efforts around the world and facilitate compliance in the pharmaceutical industry.
Understand more about MedDRA and WHODrug and find out how they can work together to standardize the manufacture and commercialization of medicines.
What is MedDRA?
MedDRA (Medical Dictionary for Regulatory Activities) is a standardized dictionary of medical terms that was created by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It is mainly used in pharmacovigilance and in the evaluation of drug-related adverse events.
It is designed to facilitate the collection, management, and analysis of drug safety data. In addition, MedDRA helps in communication between different parties involved in the manufacturing and marketing process of these products — such as regulatory agencies, companies, and healthcare professionals.
In practice, MedDRA classifies a rich highly specific and standardized medical terminology of medical terms into various hierarchies. In this way, it allows for an accurate description of adverse events, medical conditions, and other health-related aspects. Thus, the dictionary facilitates the international exchange of regulatory information on medical devices used by human beings.
That is why its use has grown a lot in the world, both by regulatory authorities and by pharmaceutical companies, clinical research organizations and health professionals. As a result, MedDRA enables better protection of patients’ health on a global scale.
What is WHODrug?
In addition to MedDRA, there is another dictionary of medical terms widely used around the world: WHODrug. It is an international classification of medicines created by the International Medicines Monitoring Programme of the WHO (World Health Organization) and managed by the UMC (Uppsala Monitoring Centre).
The main objective of the creation of the WHODrug was to standardize drug-related terminology in pharmacovigilance. Therefore, it provides a list of drug names and their classifications, facilitating the collection and analysis of data on the safety and efficacy of drugs.
Since its inception, WHODrug has been used primarily for the coding of medications in adverse event reports, allowing for more efficient data analysis.
Thus, this dictionary is a valuable tool for pharmacovigilance. It helps identify trends and patterns related to adverse reactions, promoting patient safety. In addition, it is used in clinical studies and in communication between regulatory bodies and pharmaceutical industries.
WHODrug covers several areas, such as:
- drug coding;
- categorization of active substances;
- classification of them by therapeutic groups.
In addition, WHODrug facilitates the global standardization of this information, which is essential for comparisons between different studies and reports. Therefore, it supports the implementation of ISO IDMP standards for drug identification – which is a requirement in the ICH Guides.
How MedDRA and WHODrug Impact the Pharmaceutical Market
As you can imagine, both MedDRA and WHODrug have the potential to strengthen the pharmaceutical industry around the world — especially with regard to pharmacovigilance.
Below you can learn more about the main effects that these dictionaries can have on companies, regulatory entities, and even customers in the pharmaceutical market.
Standardize industry terminology
The main objective of these dictionaries is precisely to provide unity for the sector. Therefore, both provide a common language, which facilitates the exchange of information between pharmaceutical companies, regulatory bodies, and healthcare professionals.
In this way, both MedDRA and WHODrug reduce errors and minimize misunderstandings and errors in the documentation of adverse events and the description of medications.
Strengthen quality and regulatory compliance
Consequently, when there is a standardization used by all entities in the sector, there will be fewer errors and failures. This means that the protection of the quality of the products will also be achieved.
Both compendiums make it easier to identify safety standards, speed up data analysis, and improve drug decision-making. In addition, these tools also help with regulatory compliance, making the drug approval and monitoring process more efficient.
As a result, they optimize the operation of companies, avoid failures and help companies comply with the main standards of the sector.
Protect consumers and business reputations
By adopting MedDRA and WHODrug as standard dictionaries for the terminologies used in their operations, companies promote trust in the healthcare system. After all, this optimizes processes, reduces errors, and increases product quality. The result is greater confidence in the health system.
Finally, the combination of all these benefits also ends up protecting the reputation of companies. This is because, by using tools such as MedDRA or WHODrug, a corporation demonstrates to the entire market its concern with safety, quality, and compliance.
This creates a positive perception of all stakeholders, such as regulatory entities, internal employees, business partners, and even customers.
The adoption of MedDRA and WHODrug in the US
The adoption of MedDRA (Medical Dictionary for Regulatory Activities) and WHODrug in the United States has been a critical part of enhancing pharmacovigilance and ensuring drug safety.
The United States was one of the early adopters of MedDRA when it was developed in the late 1990s. The Food and Drug Administration (FDA) began using MedDRA to standardize the reporting of adverse drug reactions and other medical events.
Over time, the use of MedDRA became a regulatory requirement for pharmaceutical companies when submitting reports of adverse events and other safety data to the FDA.
The Food and Drug Administration has encouraged the use of the WHODrug through its regulatory frameworks, particularly emphasizing its role in the international harmonization of drug safety data.
Today, both MedDRA and WHODrug are integral to the FDA’s pharmacovigilance efforts, enabling the agency to monitor drug safety more effectively and ensure that adverse events are reported and analyzed in a standardized manner.
This has helped improve drug safety surveillance and enhance public health outcomes in the United States.
Conclusion
As you have seen, pharmacovigilance is a delicate practice that requires a lot of attention, standardization, and control. That is precisely why the MedDRA and WHODrug dictionaries are so important, as they bring cohesion and ease to the quality control of medicines and medical products.
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