Abstract

Dr. François-Xavier Lacasse*

ABSTRACT

During the last decades, marketed drugs were mainly composed on small molecules and biologics. Then, biological molecules became more and more popular, followed by biosimilars. A lot of people thought that small molecules were declining.... but it was not the case for goods reasons: tablets and solid oral dosage have been and will remain successful, because of its ease of administration, the patient’s compliance, and the overall efficacy. It must be admitted that progresses have been made in orally dosed macromolecules such as oral insulin,[1] and oral COVID-19 vaccine,[2] just by checking the numerous clinical trials that have been carried out recently. In parallel to these chemical and biological drug developments, botanical plants have generated an increasing interest. According to FDA guidance entitled Botanical Drug Development Guidance for Industry,[3] “the term botanicals means products that include plant materials, algae, macroscopic fungi, and combinations thereof”. This guidance describes all the steps (chemical, non-clinical and clinical) that are needed to streamline the development of a plant into a drug product. When the word “drug” appears somewhere, it will be automatically and indefectibly associated with the Good Manufacturing Practices,[4] or GMPs, and more recently the Quality by Design,[5] or QbD, that shows how to develop a drug product with a full understanding of the critical quality attributes of the compounds that cannot be dissociated during the development with the main critical manufacturing parameters. With botanical drugs, another step was born that will give a full traceability of the plant, starting from its seeds, the way they been collected, harvested, and planted, to its growing and final collection. These steps are now managed by the Good Agriculture and Collection Practices (or GACP).[6]