Cilo Cybin Pharmaceutical recently obtained its written confirmation certificate from the South African Health Products Regulatory Authority (SAHPRA) for the standards of Good Manufacturing Practice applicable to its manufacturing plant. This is equivalent to the requirements of the European Union (=GMP of WHO/ICH Q7). Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of a high quality, safety and efficacy. SAHPRA is a participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S). PIC/S aims to develop international standards between countries and pharmaceutical inspection authorities, in order to provide constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures, and inspection capacity.
According to Article 46b (2) of Directive 2001/83/EC, active substances shall only be imported if, inter alia, they are accompanied by written confirmation from the competent authority of the exporting third country, and if the manufacturing plant confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the European Union.
Slabber says that SAHPRA has been very supportive, guiding their approach and enabling this certificate to help applicants export their flower materials to commercial markets. The certificate only allows cultivation, trimming, drying and packaging, and does not constitute a Good Manufacturing Practice license for the processing and extraction of cannabis and related products.
Cilo Cybin Pharmaceutical is in process of obtaining its Good Manufacturing Practice license for the processing and extraction of cannabis, and has been inspected by SAHPRA.
Section 22C(1)(b) of the Medicines and Related Substances Act 1965 (Act 101 of 1965) specifies that manufacturers of medicines and related substances must hold a licence. Section 35, Regulation 23 of the Act specifies that to hold a licence, there must be the ability to comply with good manufacturing practices as determined by the Authority. This allows for the Authority to determine manufacturing practices and the relevant code of GMP to be applied by manufacturers.
Slabber adds: “The South African Health Products Regulatory Authority is doing a great job in enabling applicants to cultivate, export and manufacture cannabis and related products with the applications one can apply for. We would like to thank them for helping to grow the South African economy and for ensuring best practices and standards in this new, evolving medicinal cannabis industry. They have accomplished this despite the pressure and work load since SAHPRA’s mandate was expanded to include the regulation and control of radiation emitting devices and radioactive nucleides under the Medicines Act and Hazardous Substances Act of 1973.”