On November 16, 2021, the Ministry of Health has issued the Exempt Decree No. 62 that modifies the exempt decree No. 945 that approves the technical guideline No. 170 on health registration of biotechnological products derived from recombinant DNA techniques.

The most relevant changes included in Decree No. 62 are the following:

• Update of the list in numeral X «Active Ingredients and their respective presentations with respect to which abbreviation of clinical studies may be admitted in the sanitary registration process» and «List of Reference Biotechnological Products».
• In addition to what is referred to in the list of numeral X of Technical guideline No. 170, reference biotechnological products will be considered those that are determined as such by the Food and Drugs Administration of the United States of America, the European Medicines Agency » of the European Union and the «Pharmaceutical and Medical Devices
  Agency» of Japan.

Source: www.diarioficial.cl