12 MONTHS TO DEVELOP A DRUG—PULL THE OTHER ONE, IT'S GOT BELLS ON

Big pharma's been pull your leg

PRECLINICAL TESTING OF MEDICINES

The lifecycle of a development programme for a medicinal product begins with pre-clinical assessment of a batch (lot), or batches of the active pharmaceutical ingredient (API) at small (pilot) scale. Batches are pre-GMP (GMP = Good Manufacturing Practice).

Data relating to production must be carefully recorded and collected, including but not limited to, manufacturing processes and procedures, suppliers, service providers, contract manufacturers, material specifications, development protocols, and analytical methods.

These data must be included in Module 3 (chemistry, manufacturing & controls) section of the regulatory filing. Similarly, all data applicable to Module 4 (safety) must be included in the filing.

Regulatory (FDA/EMA/MHRA) evaluation and approval to conduct clinical trials in humans ‘should’ have been based on these data.

The average timescale for this initial stage is 2 to 3 years.

The jury is out as to whether any preclinical safety testing w…