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REGULATORY ENVIRONMENT FOR TB MEDICINES

OUT OF STEP 2017

Accelerated approval Marketing authorisation can delay access to life-saving TB medicines, especially where the need for them is greatest. The pathways, requirements, local processes, timelines and capacity of NDRAs vary. A few countries lack NDRAs, while others do not always favour mutual recognition agreements or do not recognise technical assessments of SDRAs such as the European Medicines Agency (EMA) or the US Food and Drug Administration (USFDA). In 2015, WHO launched the WHO Collaborative Registration Procedure to facilitate access to generic or originator medicines, including TB medicines, for public health needs in developing countries. Participating NDRAs have 90 days to review the dossiers of SDRA-approved or WHOprequalified products, under confidentiality, in a globally harmonised format aligned with the same system used for WHO prequalification. Through this process, NDRAs can follow their national legislation and responsibilities, collect fees, and develop risk-management and pharma­ covigilance plans with applicants.123

FINDINGS: • 41% (12) of countries are enrolled in the WHO Collaborative Registration Procedure; • The following countries do not have any legal mechanisms in place to allow for the accelerated registration of medicines, including DR-TB medicines: Afghanistan, Belarus, CAR, Philippines, Russian Federation, Swaziland and Tajikistan; •  Bedaquiline is registered in six countries (Armenia, China, India, Philippines, Russian Federation and South Africa), and delamanid is not registered in any of the countries surveyed for this report; • 31% (9) of countries have all Group A medicines registered,45% (13) of countries have all Group B medicines registered, 10% (3) of countries have all Group C medicines registered, 83% (24) of countries have all Group D1 medicines registered, no country has all Group D2 medicines registered and 10% (3) of countries have all Group D3 medicines registered.  ee table 11 for registration status of bedaquiline and S delamanid across surveyed countries.

TABLE 11: REGISTRATION OF BEDAQUILINE AND DELAMANID Bedaquiline

Delamanid

Armenia, China, India, Philippines, Russian Federation, South Africa

None of the surveyed countries have registered delamanid

Daro Sulakauri/MSF

Status Registered

BEDAQUILINE FOR TREATMENT OF MDR-TB AT THE NATIONAL CENTER FOR TUBERCULOSIS AND LUNG DISEASE, TBILISI, GEORGIA.

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Médecins Sans Frontières and Stop TB Partnership – July 2017

결핵: 새 보고서 – 세계에서 가장 치명적인 감염병 결핵을 각국이 아직도 해결하지 않고 있다는 사실 드러내  

국경없는의사회와 세계보건기구(WHO) 산하 ‘결핵 퇴치 국제협력사업단’(Stop TB Partnership)은 ‘Out of Step’ 보고서 3판을 발표했다. 이 보고서는 세계에서 가장 치명적인 감염병인 결핵에 맞서기 위해 각국 정부가 더 큰 노력을...

결핵: 새 보고서 – 세계에서 가장 치명적인 감염병 결핵을 각국이 아직도 해결하지 않고 있다는 사실 드러내  

국경없는의사회와 세계보건기구(WHO) 산하 ‘결핵 퇴치 국제협력사업단’(Stop TB Partnership)은 ‘Out of Step’ 보고서 3판을 발표했다. 이 보고서는 세계에서 가장 치명적인 감염병인 결핵에 맞서기 위해 각국 정부가 더 큰 노력을...