Welcome to Regulatory Radio, brought to you by Freyr Solutions, where we discuss everything related to Life Sciences Regulatory. The second season of our podcast series strives to simplify the complex positioning of pharmaceutical advertising laws and regulations across the globe.
In the second season, we discuss the ad promo laws and regulations, offering a consolidated and high-level understanding of the laws in regulated and semi-regulated markets. With dynamic changes in the jurisdictions, compliance with the defined laws and interpretation of the concerned Health Authorities is essential.
Advertising of drugs has been a common practice adopted by pharmaceutical organizations. To protect the public from being manipulated, the Health Authorities introduce various acts to prohibit any illegal promotions. Our host provides an overview of advertising laws and regulations across six jurisdictions.
In a semi-regulated market like Zimbabwe, a considerable grey area exists between providing information and promoting medicines. Our host explores the pharmaceutical laws and regulations laid down by the Medicines Control Agency of Zimbabwe and elaborates on the key takeaways from the advertising legislative framework.
Pharmaceutical advertisement in Australia is self-regulated or co-regulated, with various bodies having their codes relevant to the promotion of drugs. Our host gives a fair understanding of how the Regulatory environment can present a challenge for companies bringing new products to the market and promoting them.
The Republic of Lithuania reflects good economic fortune for medicine manufacturers’ regional investments. To explore the Lithuanian market, manufacturers must obtain approvals from the State Medicines Control Agency. Our host gives us an insight into the Regulatory framework involved in the successful advertising and promotion of medicines.
Post-Brexit, the United Kingdom’s advertising review team scrutinizes published advertising in selected media, and we investigate referrals from colleagues in the Agency or other Regulatory Authorities. Our host addresses the necessary pharmaceutical advertising regulations a pharmaceutical organization must follow to ensure that the advertising material is thoroughly reviewed before the issue, thus avoiding misleading messages and protecting consumers from any potential negative impact.
The Mexican pharmaceutical promotional regulations for advertising drugs, governed by the Federal Commission for the Protection from Sanitary Risks (COFEPRIS), are subjected to specific requirements to protect Healthcare Professionals (HCPs) and consumers from any associated risks. In this episode, our host describes the general requirements of drugs from an advertising perspective, legislated and issued by the Code of Conduct.
The pharmaceutical advertising in Canada for prescription drugs has always been under scrutiny as laws governing Direct-to-Consumer (DTC) advertisements of prescription-only medicines are misunderstood by organizations. The governing authority for medicines, Health Canada, is responsible for general advertisement and promotions. Our host highlights the laws and regulations laid down by Health Canada.
Senior Manager, MPR RA
Neha is a chemist by training and has over ten (10) years of experience working in analytical and clinical science operations, scientific marketing, and delivery segments. She has worked on multiple projects with Regulatory Agencies and has supported companies seeking Regulatory compliance in the US and EU markets.
She is currently managing multiple projects within Freyr as a Senior Manager for MPR Consulting. She also supports Freyr’s Medical Writing domain and its marketing initiatives.