Freyr Solutions China

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2025-07-01 06:31:14 -

What is the Guidance on the Application of Permits and Licenses for Psychotropic Substances for Industrial Use in Malaysia?
The Ministry of Health (MoH), Malaysia, has issued detailed guidance on the procedures for obtaining permits and licenses to purchase, use, and store psychotropic substances for industrial purposes. These are governed under the Poisons (Psychotropic Substances) Regulations 1989 under Poison Act 1952 and related frameworks. This guidance provides clarity on the permit...

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2025-07-01 06:30:07 -

What Is NUPCO?
The National Unified Procurement Company (NUPCO) is a Saudi Arabian government-owned entity established in 2009 under the Public Investment Fund (PIF). Its primary mission is to centralize the procurement and distribution of medical supplies, pharmaceuticals, and medical devices across the Kingdom's public healthcare sector. NUPCO aims to enhance the efficiency, transparency, and...

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2025-07-01 06:29:13 -

What Is China's National Reimbursement Drug List (NRDL)?
The National Reimbursement Drug List (NRDL) is a cornerstone of China's healthcare system, determining which pharmaceuticals are eligible for reimbursement under the country’s Basic Medical Insurance (BMI) scheme. Managed by the National Healthcare Security Administration (NHSA), the NRDL aims to balance patient access to essential medications with the sustainability of...

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2025-07-01 06:28:18 -

FROM COLOMBIA TO LATAM — UNLOCKING STRATEGIC OPPORTUNITIES FOR BIOSIMILARS IN THE REGION
Colombia has established itself as a leader in biosimilar regulation across LATAM—but its role doesn’t stop there. It is now emerging as a strategic platform for expanding biosimilar products throughout Latin America. In this final installment of our series, we explore how to capitalize on biosimilar expansion opportunities, which Latin American (LATAM) markets offer the greatest...

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2025-07-01 06:26:53 -

Beyond Registration — Traceability and Pharmacovigilance in Colombia
Part 2: Beyond Registration — Traceability and Pharmacovigilance in Colombia Getting a biosimilar approved by INVIMA is just the first milestone. What truly ensures its sustainability and credibility in the Colombian market comes afterward: the consistent fulfillment of two critical pillars—traceability and pharmacovigilance. These elements have been firmly consolidated...

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2025-04-22 09:45:07 -

Agile Regulatory Strategies for a Dynamic Pharmaceutical Landscape
In today's rapidly evolving pharmaceutical industry, companies face unprecedented challenges in navigating complex regulatory landscapes while striving to bring innovative therapies to market. The convergence of technological advancements, changing patient needs, and evolving regulatory frameworks has created a dynamic environment that demands agility and adaptability. This blog explores how...

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2025-04-22 09:42:42 -

Why is Regulatory Intelligence the Key to Local PV Success?
With global health authorities continuously updating their regulations, staying ahead of these changes is vital for life sciences companies. Local PV compliance, in particular, presents a unique challenge due to region-specific regulations, reporting timelines, and stringent requirements. This is where Regulatory Intelligence (RI) in PV becomes indispensable, helping companies stay informed and...

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2025-04-22 09:40:03 -

Product Registration and Listing as per USFDA Guidelines
In the highly regulated pharmaceutical and medical device industry, Product Registration and Listing with the U.S. Food and Drug Administration (USFDA) is a fundamental requirement for manufacturers and distributors looking to introduce their products into the U.S. market. Regulatory compliance is crucial to ensure patient safety, product efficacy, and market authorization. This blog explores...

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2025-04-22 09:38:19 -

Traditional Methods vs AI-Driven Approaches of Signal Detection in Pharmacovigilance
Traditionally, signal detection relied on manual data reviews, statistical methods, and expert assessments. However, with the explosion of real-world data and adverse event reports, Artificial Intelligence (AI) and machine learning (ML) are revolutionizing how safety signals are identified and managed. This blog explores traditional pharmacovigilance signal detection methods, the emergence of...

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2025-04-22 09:36:11 -

What is Regulatory Labeling?
Pharmaceutical Regulatory labeling involves the creation, review, and management of critical documents that communicate essential product information to stakeholders, ensuring compliance with global Regulatory standards. Core components include the Core Data Sheet (CDS) and Company Core Data Sheet (CCDS), derived from sources such as Investigational Brochures and post-marketing data. This...

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2025-04-22 09:34:03 -

10-Step Guide to Regulatory Approval & Market Entry in China
China’s pharmaceutical market is projected to reach $170 billion by 2026, making it one of the most lucrative yet complex markets for global drug manufacturers. Whether you’re launching a marketed product from outside China or introducing a new drug with no prior global approvals, navigating China’s Regulatory approval process and market access landscape...

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2025-04-22 09:28:37 -

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