Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 24 November 2020 | By Nick Paul Taylor
Guidance from the Indian Department of Pharmaceuticals clarifies how companies can take advantage of an order intended to encourage the use of local suppliers of medical devices.
The order, published in September, created two groups of local suppliers that will be eligible to bid on many contract, Class I and Class II. Class I suppliers will win the full quantity of any contract for which they are the lowest bidder, while Class II or non-local suppliers who submit the lowest bid will get 50% of the work, with the remainder shared among Class I applicants. The government will categorize suppliers based on “the amount of value” they add in India but did not include thresholds for Class I and Class II suppliers.
The new guidance clarifies that to be a Class I local supplier, a company needs at least 50% local content. Local content is the amount of value added in India, which is calculated using the value of a device and its imported elements. If a medical device is valued at $100 in a procurement contract and the value of its imported content is $50, the local content is 50%.
The guidance also puts suppliers of devices with 20%-50% local content in Class II and categorizes those with less than 20% local content as non-local, cutting them off from some procurement contracts.
Suppliers need to calculate the percentage of local content of a product and submit the information when they bid for a contract. The guidelines call for suppliers to self-certify that the item meets the Class I or Class II criteria and share details of where the local value addition takes place. An auditor or practicing chartered accountant needs to provide a certificate for contracts over Rs 100 million ($1.4 million). Suppliers need to pay a fee, refundable in the event of victory, to lodge a complaint.
TGA finds 30% of metformin batches exceed nitrosamine limit
Australia’s Therapeutic Goods Administration (TGA) has found 30% of tested batches of immediate- and extended-release metformin medicines contained N-nitrosodimethylamine (NDMA) levels that “modestly” exceeded the acceptable limit.
TGA began probing potential nitrosamine contamination of “a small number” of metformin products late last year in response to evidence generated by overseas regulators. The investigation found 30% of the tested batches contained NDMA levels of up to twice TGA’s acceptable limit. One metformin batch had NMDA levels 4.4 times above the limit.
The batch that was 4.4 times above the limit has been recalled from wholesalers. TGA is taking a different approach to the other batches as it calculates they pose a very low risk to patients.
TGA is working with metformin manufacturers to improve the production and testing of the medicines as part of a global push to reduce levels of nitrosamine contamination in multiple medicine classes.
Japan’s PMDA posts white paper on the quality and safety of gene therapies
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published its Science Board’s white paper on the quality and safety of gene therapies. The paper provides an overview of issues including off-target effects and the importance of long-term follow-up in clinical trials.
The paper takes a broad approach to gene therapy, addressing technologies including viral vectors, mRNA and ex-vivo genome editing. The paper lists the cancer risk of gene-edited cells and the risk of unintended gene modification in germline cells among the harms that could be caused by genome editing. PMDA also lists cautions specific to different technologies.
Another section addresses approaches to evaluating and mitigating different risks. For example, the paper addresses the sgRNA design considerations that can reduce the risk of CRISPR/Cas9 causing off-target effects. The paper favors long-term follow-up of participants in gene therapy clinical trials, although the exact length depends on the technology.
The Science Board, a high-level consultive body, plans to update the white paper as technology advances. PMDA shared the white paper alongside a link to a journal article about genome editing in Japan that was published last month.
China puts Astellas and Biogen drugs on new list of urgently needed medicines
The Center for Drug Evaluation (CDE) has released a third list of medicines that it wants to see come to market in China, including seven drugs from companies including Astellas Pharma and Biogen.
In 2018, CDE offered a regulatory fast track to 48 drugs that were approved overseas but not available in China. The initiative was intended to enable companies to start selling some medicines in China based on a racial sensitivity analysis and postmarketing plan. CDE would rely on the product’s history of use overseas to support safety and efficacy.
Soliris and other drugs on the original list subsequently won approval in China, leading CDE to offer the fast track to another 30 medicines in 2019.
Most of the drugs on the most recent list were only approved overseas for the first time in 2018. The oldest item on the list is the multiple sclerosis medicine Tecfidera (Biogen) . CDE selected the products on the grounds that they address urgent clinical needs in China.
CDE Notice (Chinese)
Philippine FDA seeks applicants for compassionate use pilot project
The Philippine Food and Drug Administration (FDA) has opened its eServices Portal System for use by applicants seeking Compassionate Special Permits to use unregistered medicines.
FDA has already begun using the portal for authorization permits for health establishments including organizations that handle drugs. For one month from 19 November, FDA will also permit use of the portal for applications to provide medicines on a compassionate use basis under a pilot evaluation of the system.
People can use the portal to seek compassionate use permits without creating an account. FDA will reject incomplete applications during a pre-assessment step. Applicants that advance to the second stage need to pay a fee to have their applications fully assessed by FDA.
The pilot project closes on 19 December. FDA is accepting feedback on the portal.
Regulatory Focus newsletters
All the biggest regulatory news and happenings.