Blog & Article
- 20th November 2025
Journal Articles
Journal Article
PharmaLex was established 25 years ago with a vision to make a difference to how the industry interacts with regulatory authorities.
Journal Article
Heightened interest in small molecules is likely to continue in 2023 and beyond as several biotech companies look beyond biologics to bring medicines to patients in need.
Journal Article
The European Medicines Agency (EMA) was true to its word in 2022. While pharmaceutical companies involved in manufacturing sterile products were assessing the text of Draft Revision 12 of Annex 1 to the European Union’s good manufacturing practice (GMP) regulations, the final approved revision was published on 25 August 2022 (1), bringing an end to speculations about what it would include.
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Efforts to build greater harmonization between global regulators are gathering momentum, partly due to changes brought about by COVID. This growing trend is likely to continue as regulatory authorities gain increasing confidence in collaborative initiatives that are still in their infancy.
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The demands on life sciences companies are constantly intensifying. Resource constraints – whether workforce or the need to cut costs or streamline processes – different global regulatory requirements and the need to stay on top of technology advances create an increasingly complex environment for the industry.
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The Life Science Sector has been undergoing an immense transformation, driven by the adoption of artificial intelligence (AI), machine learning (ML), natural language processing (NLP), and big data.
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Companies in the life sciences industry must ensure they have the systems and tools to be able to consistently provide a product that is safe and effective and that is delivered in a timely manner to meet the needs of customers, in addition to an efficient and agile support system for resolution of unexpected situations.
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Even though this is true in any business sector, it is particularly important for companies in the life sciences industry, where personnel must deal with many complex processes in a highly regulated environment to ensure both product and operations are compliant.
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Efforts to improve the regulatory review process through standardization, harmonization, and digitalization have gathered steam in recent years with regulators and industry alike pushing forward with data-driven initiatives. Guest contributors from PharmaLex discuss what these mean for 2023 and beyond.
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With thousands of outstanding conformity assessments for medical device certification under the Medical Device Regulation and limited capacity to manage these within the transition period, concerns over widespread product shortages in the EU market have been growing.
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The start of 2023 has been challenging for the pharmaceutical industry. Economic constraints in Europe and the United States, staffing shortages, an increasingly complex regulatory environment and heightened competition for funding is putting pressure on companies
Journal Article
The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) once again cosponsored the 2022 PDA/FDA Joint Regulatory Conference with the theme, “Quality Evolution/Technology Revolution: Modern Quality Management Solutions.” Due to the COVID-19 pandemic, there became a pressing need to address the public health crisis, which led to some introspective thinking among industry and regulators about improving communication and embracing innovation and technology. This emphasis on improvement was the overarching message from the PDA/FDA conference.