INFO KGV | LIFE SCIENCES JUNE 2019

ANVISA PUBLISHES CONSULTATIONS ON CANNABIS-DERIVED DRUG REGULATION

 

On June 14, the Brazilian Health Surveillance Agency (ANVISA) published two Public Consultations:

• CP No. 654/2019 (Portuguese Language) on the specific procedure for registering cannabis-derived drugs; and
• CP No. 655/2019 (Portuguese Language) on the requirements for cultivating cannabis species for scientific and medicinal purposes.

None of the activities covered by the consultations have been previously regulated by ANVISA. The key points advanced by the draft regulations proposed in the consultations are:

• Cultivation will only be allowed in indoor controlled areas, subject to strict safety measures and annual cultivation quotas.

• Cannabis species may be sold only to research institutions and licensed manufacturers of medicines and active pharmaceutical ingredients

• ANVISA will only approve cannabis-derived drugs that are designed to be orally administered and are indicated for debilitating diseases.

• In certain situations, an applicant may apply for registration without some of the documents that would normally be required to complete the application dossier (such as data from long-term stability testing and phase III clinical studies). The relevant drug may be approved on the basis of that application, but these missing documents must then be presented within the first three years after approval.

Responses to the consultations may be submitted until 18 August 2019.

 

“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”

 

FEDERAL SUPREME COURT RULES ON RIGHT TO OBTAIN STATE-FINANCED UNREGISTERED DRUGS

Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno, César Santos Borlina, and Leonardo Barboni Rosa, Kestener Granja and Vieira Advogados

 

On May 22, 2019, the Federal Supreme Court rendered a ruling on whether the constitutional right to receive treatments free of charge within the Unified Health System (SUS) includes the right to obtain unregistered drugs financed by the State. The decision was issued in Extraordinary Appeal No. 657718 (Portuguese Language).

According to the decision, where the Brazilian state is required to fund unregistered drugs, no experimental drugs shall be supplied, and as a general rule, the State shall not be obliged to supply unregistered drugs unless all of the following requirements are met:

• The registration dossier has already been filed;
• The Brazilian Health Surveillance Agency (ANVISA) is taking unjustifiably longer than prescribed by law to analyze the drug’s registration;
• The drug is registered with renowned foreign surveillance agencies and has no therapeutic substitute registered in Brazil.

The decision brings some long-awaited guidance on an ongoing discussion in the courts ever since the enactment of the 1988 Constitution and is expected to help alleviate public expenditure on health treatments.

 

“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”

 

 

ANVISA OPENS PUBLIC CONSULTATION ON GMP GUIDELINES

Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno, César Santos Borlina and Leonardo Barboni Rosa, Kestener Granja and Vieira Advogados

 

On May 27, 2019, the Brazilian Health Surveillance Agency (ANVISA) published Public Consultation No. 653/2019 (Portuguese Language), on a series of Good Manufacturing Practices (GMP) guidelines for drugs manufactures.

The consultation is an attempt to implement standards developed by the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S is a non-binding, informal cooperation arrangement between regulatory authorities. The drug regulatory authorities of most major nations are members, and PIC/S seeks alignment with EU GMP standards by collaborating with the EMA.

Since ANVISA’s intention is to harmonize its standards with those of the international community, the scope of requested contributions to the consultation is to address specific questions regarding:

• The accuracy of the proposed translation of PIC/S guidelines into Portuguese.
• The feasibility of complying with the guidelines within the proposed timeframe; and
• Whether different requirements are necessary to ensure an appropriate safety level.

ANVISA publishes consultations on cannabis-derived drug regulation

Contributions in response to the consultation may be submitted until August 2, 2019.

 

“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”