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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016. Reforming the World Health Organization’s Essential Medicines List: Essential but Unaffordable. Limitations on the Capability of the FDA to Advise. Value Health. JAMA Intern Med. 2022 Oct 3:e224226.

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How the Medical Industry Can Help Combat the Current Coronavirus Crisis

Exeed Regulatory Compliance

Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. The World Health Organization (WHO) has stopped short of classifying the outbreak as a pandemic, but consistently encouraged affected countries to activate their national emergency response plans.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

A new template for the Certificate of a Pharmaceutical Product will be put into use in line with China’s pharmaceutical export practices and the latest World Health Organization (WHO) guidelines. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

SQA

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. These products are widely used by Canadians.

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The Global Challenge of Unhealthy Diets: Front-of-Package Labeling for America

Bill of Health

Food and Drug Administration (FDA) is expected to propose new rulemaking on front-of-package labeling in 2024. The World Health Organization (WHO) has recommended FOP labeling as a cost-effective intervention to improve population-level dietary habits. Since 2009, the U.S. No standardized system exists but the U.S.