Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
CDSCO Seeks Feedback on Planned Risk-Based Pharmacovigilance Inspection Program
The Central Drugs Standard Control Organization (CDSCO) is seeking feedback a proposed risk-based pharmacovigilance inspection model. CDSCO plans to adopt a four-year cycle for pharmacovigilance inspections and prioritize the assessment of companies that introduce new drugs to the market.
Indian legislation tasks companies with setting up post-marketing surveillance programs that collect and process adverse event data for forwarding on to the licensing authority. CDSCO published a guide to help marketing authorization holders comply with these requirements around the start of the year, but has said less publicly about how it will enforce the rules. That began to change last month when the regulatory agency met with industry groups to discuss the draft guidelines it was developing.
Having presented the guidelines to those groups, CDSCO has now shared the document publicly. The strategy proposed by CDSCO has two components. CDSCO will conduct routine inspections of drug companies every four years. The exact time between inspections will depend on CDSCO’s perception of the risk posed by a company. In parallel, CDSCO will conduct “triggered” inspections of companies it has reason to think may not be complying with the pharmacovigilance requirements.
The draft guidelines set out how CDSCO will prioritize routine inspections. Companies with new drugs on the market will move toward the top of the queue. CDSCO will also factor in the company’s inspection history, whether it outsources some or all of its pharmacovigilance activities and its sales volumes. Finally, CDSCO will pay particular attention to companies that make a lot of post-approval changes or are the subject of complaints by government bodies and procurement agencies.
These and other types of information will inform CDSCO’s routine risk-based inspection schedule. At the same time, CDSCO will run a targeted inspection program that is triggered by other, more serious pieces of information. CDSCO will consider running a targeted inspection when it learns a company has failed to meet its product safety obligations on time, when it receives incomplete periodic safety update reports and when a drug is pulled from a foreign market with little or no advance notice.
CDSCO is accepting feedback on the draft until the end of October.
India Posts Draft Guidelines on Good Distribution Practices
CDSCO has released draft guidelines on good distribution practices (GDPs) for consultation. The text discusses what CDSCO expects of all companies in the supply chain in terms of personnel, quality systems and other matters essential to GDP compliance.
India’s CDSCO created the guidelines to give all people and organizations involved in the storage and distribution of drugs pointers on how to ensure products meet quality standards and are authentic. To achieve that broad goal, CDSCO has put together a 21-page document that addresses a wide range of topics, from the training of staff through to how to map the temperature of storage areas.
In terms of staffing and organization, CDSCO expects companies to clearly establish responsibilities for all supply chain employees and ensure they are properly trained. Each company must give one person responsibility for ensuring a quality system is implemented and maintained.
The guidelines require all distributors of pharmaceutical products to establish and maintain a quality system supported by a documented quality system. Responsibility for ensuring all parts of the quality system are “adequately resourced with competent personnel and suitable and sufficient premises, equipment and facilities” falls on senior management. CDSCO expects managers to ensure product quality is not put at risk by the overburdening of employees with responsibilities.
Other sections of the guidelines cover the documentation required to comply with GDPs. Companies should ensure drugs can be traced the full length of the supply chain, from manufacturer to retailer, using the available documentation. These documents should feature details such as expiry dates and batch numbers. CDSCO wants companies to retain documents until one year after the expiry date of the product they relate to.
These documents will be useful in the event a product is recalled. Companies should also have written procedures covering the management of recalls and give a member of staff responsibility for overseeing the process.
The guidance also addresses spurious pharmaceutical products. CDSCO wants companies to respond to the discovery of spurious products by separating them from legitimate drugs and labeling them as not for sale. The company should also tell national regulatory authorities about its discovery without delay and suspend the sale and distribution of any suspect products. If the products are confirmed to be spurious, authorities will make a formal decision about their disposal.
CDSCO has opened the draft up for a three-week comment window.
TGA Sees Slump in Orphan Drug Designations Following Regulatory Reforms
Australia’s Therapeutic Goods Administration (TGA) has reported a year-on-year drop in the number of orphan drug designations it awarded. The 45% decline covers the period in which TGA adopted new eligibility criteria and otherwise overhauled its approach to drugs targeting rare diseases.
In the 12 months preceding the introduction of the new program in July 2017, TGA signed off on 29 orphan designations. Over the following 12 months, the number fell to 16. Five of the designations awarded over the past year covered applications made prior to July 2017 under the old orphan drug program.
As the eligibility criteria changed in July 2017, TGA said the designation data for the 12 months either side of that month “are not directly comparable.” However, the data nonetheless show changes to the program have coincided with a decrease in the number of orphan drug designations.
TGA presented the data in its annual report. The report also shows a sharp increase in the number of targeted compliance and restricted word reviews of medical devices. TGA commenced 122 restricted word reviews to identify applications for Class I devices last year. In the preceding year, TGA started 55 restricted word reviews. The number of targeted compliance reviews rose even faster, jumping from 45 to 211.
Other big swings in the TGA data include a sharp fall in the number of targeted reviews of listed medicines. TGA initiated 504 targeted reviews from July 2016 to June 2017. Over the following year, TGA began 82 targeted reviews.
India Admits it is Missing Hundreds of Performance Reports on Drug Inspectors
CDSCO has told the heads of its offices to submit hundreds of missing annual performance appraisal reports (APARs) for drug inspectors. The list shared by CDSCO’s deputy director for administration shows the offices have failed to submit reports going back to 2013 on 219 inspectors.
India established the APAR system to support oversight of how senior officials at public bodies fare against their annual performance goals. However, the impact of the system at CDSCO is undermined by the failure of people at its headquarters and many regional offices to submit the reports on time.
Most of the outstanding reports cover the last financial year. Some date back much further, though. The list shared by CDSCO includes several missing reports from 2013. Four years worth of reports on some drug inspectors are missing.
Vum Mang, the official who issued the notice, wants the CDSCO leaders responsible for the reports to urgently complete and submit the staff appraisals.