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Online Eligibility Checker Tool for International Recognition Procedure

Blogs, Regulatory /

The International Recognition Procedure (IRP), initiated by the Medicines and Healthcare products Regulatory Agency (MHRA) post-Brexit, establishes an international recognition route for medicines with pre-existing approvals from Canada, Australia, the EU, Japan, Switzerland, and the US. Operating alongside existing national procedures, the IRP is a crucial pathway for introducing innovative medications to UK patients while […]

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UK MHRA: Navigating Nuances in Clinical Trial Applications

Blogs, Clinical Regulatory, Regulatory /

The UK Medicines and Healthcare products Regulatory Agency (MHRA) receives approximability 1000 clinical trial authorization (CTA) applications a year. These are for investigational medicinal products of which >95% are approved. However, >50% still need additional information to be submitted in order to get approved. The majority of the requests for additional information, including “grounds for

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Fostering bilateral trade and harmonized efforts in medicine regulation

Blogs, Regulatory /

The importance of aligning pharmaceutical regulations in the development process has become increasingly evident particularly in the current era that has characterized by global interconnectedness. Indeed, the need for harmonizing frameworks that govern medicine regulation and subsequently supporting bilateral trade has increasingly become imperative. As various pharmaceutical markets go beyond borders, disparities in their respective

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ANVISA & ANMAT: Mutual Recognition Agreement for Medical Devices

Blogs, Medical Device, Regulatory /

The medical device sector in Argentina and Brazil is experiencing robust growth and development to keep up with the demand in more comprehensive options to diagnose, prevent, and treat complicated conditions. Indeed, rising healthcare demands and an increase in the awareness of advanced medical technologies propel a surge in the adoption of innovative devices. Coupled

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Advancing Healthcare through Electronic Product Information

Blogs, Labeling, Regulatory /

Electronic Product Information (ePI) is authorized, statutory information for medicines, covering patient information leaflets and the Summary of Product Characteristics for healthcare professionals. It adheres to a semi-structured format with the common EU electronic standard, optimized for electronic handling, internet dissemination, and compatibility with healthcare information systems. Despite print options, the primary aim of ePI

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How is EMA Addressing Medicine Shortages in Europe?

Blogs, Regulatory /

The emergence of drug shortages as a significant global health concern is evident. Organisations including the European Medicines Agency (EMA) express concerns about long-term medicine availability, emphasizing the need for continuous access to high-quality, affordable essential medicines.  Shortages lasting days or months jeopardize patient outcomes, straining healthcare systems. EMA has introduced a solidarity mechanism, developed

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Kenya’s Systematic Approach to Pharmacovigilance

Blogs, Pharmacovigilance /

Pharmacovigilance (PV) and drug safety surveillance activities rely on a robust PV system. This is important to effectively identify, evaluate, and address any adverse events (AEs) that are associated with medicinal products. Indeed, a proficient PV system facilitates data gathering that is critical for making informed decisions across various health systems. Regulatory agencies are reliant

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MHRA’s AI-Airlock for Safe Development of Medical Technologies

Blogs, Medical Device, Regulatory /

The use of artificial intelligence (AI) in the Pharmaceutical and Health Care industries has paved the way for more innovative opportunities to help enhance patient outcomes. This is with respect to the diagnosis, treatment, and overall personalized patient care. However, as these technologies evolve, so do the challenges especially when it comes to testing these

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Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices

Blogs, Medical Device, Regulatory /

As more artificial intelligence (AI) and machine learning (ML) technologies become increasingly available, the uniqueness of medical devices also evolve. Though AI/ML-driven devices provide support for diagnosing and treating more complex conditions, their unique features highlight the need for a more harmonized approach towards device regulation for patient safety. Regulators across the globe are gradually

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ISoP: The Need for Patient Engagement in Pharmacovigilance

Blogs, Pharmacovigilance /

Pharmacovigilance is paramount for the well-being of patients exposed to pharmaceutical products. To ensure the effectiveness of pharmacovigilance systems professionals from various scientific disciplines contribute in diverse manner. Several organizations collaborate to ensure best global pharmacovigilance practices for patient safety. Among these key organizations is the International Society of Pharmacovigilance (ISoP) that is dedicated to patient

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