Colombia Harmonizes Vaccine Regulations, Clarifies Preclinical, Clinical Requirements

September 26, 2013
Companies seeking to market vaccines in Colombia must provide the drug regulatory authority with the results of Phase IV studies, details of each study’s protocol and a complete pharmacovigilance plan, new technical information released by INVIMA says. Submissions for vaccines containing known or previously used antigens must include results of immunogenicity and safety studies, the agency adds.
International Pharmaceutical Regulatory Monitor