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Posted 30 August 2016 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
The Drug Controller General of India (DCGI) has ordered companies to self-assess their compliance with good manufacturing and laboratory practices (GMPs/GLPs). DCGI is demanding manufacturers carry out the self-assessment, award themselves a quality rating and submit the resulting report to the relevant regulatory officials by mid-November.
Officials at the Central Drugs Standard Control Organization (CDSCO) have put together a checklist and accompanying benchmarks to help manufacturers perform GMP-GLP evaluations. The checklist draws on India’s Schedule M and Schedule L-1 legislation, which respectively cover GMPs and GLPs, as well as World Health Organization (WHO) drug quality expectations and Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards.
The benchmark element of the materials created by CDSCO is designed to give drug production sites a rating based on the risk they are thought to pose to patients. By having manufacturers assess their own facilities against this benchmark and evaluate their compliance with GMPs and GLPs, regulators in India stand to gain access to an overview of the production plants that pose the greatest risk to patients, either because of the nature of their work or their quality practices.
DCGI’s decision to place the burden for making these assessments onto manufacturers is reminiscent of the strategy pursued by China Food and Drug Administration (CFDA). Earlier this month, CFDA told manufacturers in China to self-assess their production process standards and report back by the start of October. The demand, which is very similar to that made by DCGI, follows other requests for firms to self-assess the quality of their regulatory filings and other aspects of their businesses.
CFDA claims the approach has delivered some success, notably in terms of shortening its backlog of regulatory submissions. The question facing DCGI is the extent to which manufacturers will comply with the request, and what it can do if they ignore the order. In recent years, India has been forced to extend deadlines for the implementation of track and trace, compliance with a marketing code and submission of data on fixed-dose combinations, in part because of resistance from industry.
The Therapeutic Goods Administration (TGA) of Australia has started a consultation on autologous cell and tissue products. TGA initiated the debate to help it decide on its regulatory approach toward autologous therapies, a class of products it fears is exposing patients to unnecessary risks.
Autologous therapies are defined by the administration of a patient’s own cells back into them. Many leading lights of the immuno-oncology sector are developing autologous cell therapies, but the field is also host to healthcare professionals who perform medical procedures involving extracting and administering cells. When TGA looked at the topic in 2011, it left oversight of such healthcare professionals to state officials, but it now has doubts about whether this is the right approach.
Faced with the rise of direct-to-consumer advertising of autologous therapies, evidence that doctors are extensively manipulating cells prior to administration and reports of adverse events, TGA is considering bringing more of the sector under its purview. One of the key questions TGA puts to the industry in the consultation document is to what extent it should regulate autologous therapies. The regulator has proposed four approaches.
At one end of the spectrum, TGA is proposing to essentially continue with its current light-touch approach. The most extreme change would see TGA regulate all autologous therapies except those that are neither advertised to consumers nor more than minimally manipulated. Options two and three fall somewhere between these two regulatory approaches. TGA has given the industry until 6 October to provide feedback.
TGA Alert, Consultation Paper
CFDA has released draft guidance on data integrity in clinical trials for consultation. The text sets out the responsibilities of sponsors, contract research organizations (CROs) and trial sites, as well as the punishments they can face for failing to meet CFDA’s data integrity expectations.
In writing the guidance, CFDA has condensed different pieces of legislation that relate to the integrity of clinical trial data into a single document. Once the document has detailed the responsibilities of sponsors, CROs and investigator sites with regard to clinical trial data authenticity and traceability, it draws on CFDA’s good clinical practices (GCPs) to state unequivocally that some actions are illegal in China.
The modification, fabrication, concealment and destruction of various types of data are all prohibited explicitly in the guidance. CFDA has also used the text to state the illegality of a company substituting drugs from other manufacturers for its own for use in regulatory tests. None of this should be news to manufacturers, but with the reform program in China gathering evidence of fraudulent clinical trial activity, CFDA has decided to clearly convey what is expected.
CFDA has also laid out what will happen to companies that fail to comply with the guidance. Officials have made the punishment of clinical trial fraud a top near-term priority, and the guidance is in line with this policy. The text details a litany of regulatory punishments CFDA will apply to organizations and individuals that knowingly, fraudulently manipulate clinical trial data. CFDA is working with the legal system to ensure fraudsters are punished through the courts, too.
CFDA Alert (Chinese)
DCGI has raised the level of qualification needed to work in drug production plants. At the start of 2018, DCGI will ban manufacturers from employing anyone who lacks a formal degree or diploma in a relevant field or certification from the Life Sciences Sector Skill Development Council.
The stipulation is part of a broader initiative to raise standards at manufacturing plants by improving the skillsets of their workforces. As such, DCGI is doing more than giving manufacturers another box to check when hiring people to work at their facilities. The regulator is also trying actively to help the industry raise standards by telling the aforementioned skills development council to create qualification packs, also referred to by DCGI as national occupational standards.
In anticipation of the incoming qualification requirements, the skills council has begun offering two types of certification: “Post fresh skilling and assessment of eligible youth,” and “post assessment under ‘recognition of prior learning (RPL)’ for existing workforce in industry.” RPL is a way to recognize the skills people have gained on the job and through other informal means that do not result in the type of qualification needed to comply with DCGI’s requirements.
Manufacturers now have 16 months to ensure all their workers have the necessary qualifications. The skills council process is designed to make this task straightforward. People can work through the council’s training programs on their computers or smartphones. At the end of each unit of the training program, users must complete a test to assess their comprehension of the module. A score of 80% or more is needed to progress to the next stage of the program.
Tags: TGA, DCGI, GLP, GMP, stem cells