Regulatory/Legislation

Your NDC Numbers are About to Change

August 1, 2022

By Eric Foxman, AAHP Secretary FDA has published a proposal that will change the required National Drug Code (NDC) format from 10 to 12 digits. Once finalized, all NDC holders…

House and Senate Advance FDA User Fee Reauthorization Bills

June 29, 2022

By Pete Evich In the month of June, both the House and Senate advanced separate pieces of legislation that reauthorize FDA’s prescription drug, medical device, biosimilars, and generic drug user…

The Status of Homeopathic Medicinal Products in the European Union

June 7, 2022

By European Coalition on Homeopathic & Anthroposophic Medicinal Products (ECHAMP)   Homeopathic medicinal products have a strong foundation in the EU law. Specific EU legislation for homeopathic medicinal products has…

FDA Seeks Accelerated Drug Approval, DSHEA, Cosmetics Legislative Reforms

June 3, 2022

By Pete Evich, AAHP Government Relations As part of the President’s FY 2023 Budget proposal, FDA has called upon Congress to take up legislation that would give the agency additional…

The Regulation of Homeopathic Medicines in 2022

June 3, 2022

By Mark Land, AAHP President   The content in our June 2022 newsletter on regulation turned out quite different than I imagined when we discussed it at an editorial planning…

Regulation of Homeopathic Medicines in Canada

June 3, 2022

Submitted by David Skinner, Canadian Homeopathic Pharmaceutical Association   Homeopathic medicines (HMs) are regulated in Canada by Health Canada, the federal government department responsible for ensuring the safety, efficacy, and…

Regulatory Status of Homeopathy in the EU & UK: What’s Happened Since Brexit?

June 3, 2022

By Steve Mann, Director of External Regulatory Affairs, Nelsons   To say the world has changed over the last couple of years might just be the understatement of the century…

A Global Perspective on Effectiveness Standards for Homeopathic Medicinal Products: Is there a “Third Way”?

June 3, 2022

By Robbert van Haselen, Chair, HPCUS Clinical Documentation Committee; Director, World Integrated Medicine Forum   We currently live in an increasingly polarized world, and this is also reflected in the…

Be ’Recall Ready’: FDA Wants to Help You Fulfill Your Regulatory Requirements

April 1, 2022

By Eric Foxman, AAHP Secretary Does your company market or distribute an FDA-regulated product? If so, then FDA has a document for you. FDA wants all manufacturers and downstream distribution…

Meet the Incumbent FDA Commissioner, Robert Califf, MD

February 25, 2022

Prominent cardiologist Robert Califf, MD, will once again serve as FDA Commissioner after being confirmed by the Senate on Feb. 15. Dr. Califf was first nominated to the position by…

AAHP monitors and reports on current federal regulations, legislation and government policies that affect the homeopathic community. AAHP is often the first to learn of regulatory changes that have both direct and indirect effects on our industry enabling members to stay ahead of the curve in a rapidly changing healthcare environment.

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