ICH

Understanding the ICH Q12 Guideline: Enhancing Pharmaceutical Lifecycle Management

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The International Council for Harmonisation (ICH) Q12 guideline, titled “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” provides a framework to streamline the management of post-approval changes for pharmaceutical products. Finalized in 2019, ICH Q12 aims to harmonize regulatory expectations, promote innovation, and ensure a consistent supply of high-quality medicines. By introducing tools like … Read more

Does every country have FDA ? How many countries follow WHO, ICH, USFDA, EDQM guidelines?

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Regualatory agencies -pharma industry

Many of us may be wondering whether every country has FDA like regulatory agencies. The answer to this is No. Not every country has an FDA-like regulatory agency for the pharmaceutical industry. However, many countries have established regulatory agencies to oversee the safety and efficacy of pharmaceutical products sold within their borders. Some examples of … Read more