In the highly regulated and dynamic pharmaceutical industry, medicinal product-related promotions and advertisements aim to increase brand awareness, generate sales, or create brand loyalty.  A high amount of pharmaceutical budget (nearly 9.3 million U.S. dollars in 2022 as per Statistics (Marketing budgets of U.S. healthcare companies 2019-2022; Published by J. G.

In recent years, Regulatory bodies have adapted to new technologies and compliance demands by implementing remote inspections. This shift, accelerated by the COVID-19 pandemic, has allowed these agencies to continue monitoring compliance while minimizing physical interactions.

The pharmaceutical industry is awash in data, from clinical trial results to patient medical records. This trove of information is invaluable for developing new drugs and therapies, but it also presents a significant challenge when it comes to data protection.

In the intricate world of pharmaceuticals, where meticulous research meets stringent regulations, a crucial document plays a pivotal role in ensuring the safety, efficacy, and quality of drugs: the Drug Master File (DMF). Often referred to as the silent cornerstone of Regulatory submissions, DMFs are shrouded in importance and intricacy.

In the dynamic world of pharmaceuticals, the role of real-world data (RWD) and real-world evidence (RWE) is becoming more pivotal. These tools provide a bridge between the controlled environment of clinical trials and the real-world complexities of patient care. Several pharmaceutical companies have successfully used RWD/RWE to support their regulatory submissions.

米国において、待望の化粧品規制の更新である化粧品規制近代化法 （Modernization of Cosmetics Regulation Act of 2022、以下MoCRA）が 2022 年 12 月 29 日に署名され、化粧品および化粧品施設に対する規制の監視が強化されました。MoCRA は現行の規制枠組みに大きな変更をもたらし、1938 年の連邦食品医薬品化粧品法 （FD&C 法） の制定以来の顕著な転換となります。

MoCRA 化粧品 スケジュール

The highly anticipated cosmetic Regulatory update, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), was signed into law on December 29, 2022, ushering heightened Regulatory oversight of cosmetic products and facilities.

Nicotinamide Mononucleotide (NMN) has been making waves in the world of dietary supplements. Touted as a potential fountain of youth and an elixir for longevity, NMN supplements have gained popularity among health enthusiasts. However, there's a catch: the Food and Drug Administration (FDA) has imposed restrictions on NMN dietary supplements, including FDA-approved food supplements. But why?

According to the World Health Organization (WHO), only 27% of lower-middle-income and low-income economies have national pharmacovigilance systems registered with the WHO program, compared with 96% of the high-income countries in the Organisation for Economic Co-operation and Development.

In the realm of modern medicine, hope has taken on a new form - Advanced Therapy Medicinal Products (ATMPs). These groundbreaking therapies, utilizing genes, cells, and tissues, hold the potential to cure diseases that were once deemed incurable. Yet, within this potential lies a complexity that challenges the very core of pharmacovigilance.