Spring Intro 2023

03/03/2023

Content

• A little history ● …why does Regulatory Affairs as a discipline/ function exist? • Pharmaceutical legislation • Evolving EU Regulatory environment • The EU Regulatory procedures & decision makers

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A little history....

• First Pharmacopoeias and formularies - Europe appeared in C15th / C16th: ● Henry VIII enacted the first English law to control medicines (following pressure from the College of Physicians) in 1540 ● The first Spanish Pharmacopoeia issued in 1581 ● The London Pharmacopoeia in 1618 • Many centuries of updating……

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