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Cost recovery implementation statement 2016-17
V1.0 June 2016
Cost recovery model
Outputs and business processes of the activity
1. Prescription medicines
Higher risk medicines, such as prescription medicines, must be registered on the ARTG before they are made available for sale in Australia.
Prescription medicines are available from a pharmacist, supplied with a doctor's prescription. Otherwise, only authorised health care professionals can supply prescription medicines, such as in a hospital setting. Examples include vaccines, blood pressure tablets, diabetes medications, contraceptive pills, antibiotics and strong painkillers.
There are some legal exemptions to the requirement for a prescription medicine to be registered on the ARTG before they are supplied in Australia. These are implemented through:
- the Special Access Scheme (SAS); and
- the clinical trials systems (CTX and CTN)
The business area responsible for administering these exemptions ensures that they are administered in accordance with the legislative and regulatory frameworks.
As the TGA operates on a cost recovery basis, to enable pre- and post-market regulatory activity there are a number of fees and charges for medicines. These include annual charges, application fees and evaluation fees.
Regulatory framework
Regulatory decisions are made within a framework of guidelines. The guidelines must maintain currency with scientific and technical developments.
International regulators, or regulator groups such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, may publish guidelines that are reviewed and may be adopted by the TGA.
Registration on the ARTG
Before being placed on the ARTG, prescription medicines are assessed for quality, safety and efficacy. This utilises the following process.
Applications
All applications for registration of prescription medicines must be preceded by a pre-planning submission form (PPF). TGA assesses all PPFs to ensure that application dossiers for registration on the ARTG contain all the appropriate and required information. The information provided in the PPF allows resources to be effectively assigned to the evaluation process. If the PPF is insufficient for planning purposes or indicates that mandatory requirements have not been met, the TGA may deem the PPF to be 'not effective' and the application will not proceed to the dossier submission stage. The submission of the PPF improves the quality of applications and helps in meeting legislative timeframes.
Data evaluation
The data submitted with an application is divided into three types.
- Quality data evaluated by chemists, biochemists, microbiologists and other TGA officers includes:
- the composition of the drug substance and the drug product
- batch consistency
- stability data
- sterility data (if applicable)
- the impurity content
- non-clinical data evaluated by toxicologists
- pharmacology data
- Toxicology data
- Clinical data evaluated by a medical doctor (mostly results of clinical trials)
Decision making
Before making a decision around the suitability of a prescription medicine for registration on the ARTG, the delegate may take into consideration independent expert advice provided by the Advisory Committee on Prescription Medicines.
Regulatory decisions in relation to new chemical entities or fixed dose combination products are published through the Australian Public Assessment Report (AusPAR).
Any person whose interests are affected by the decision may seek a reconsideration of the decision under section 60 of the Act.
Applications to change details of registration
Once a product has been registered, the sponsor can make further applications to change the details of registration. Some examples of the types of change that might be applied for include:
- a change in manufacturer;
- an increase in shelf-life;
- a change in patient population (e.g. allowing children to use the medicine); and
- changing the intended use (usually adding an extra medical condition that can be treated).
Changes may or may not require evaluation of data by the TGA and the prescribed fees apply accordingly.
Export
Medicines for export from Australia must be of a similar quality and safety standard as those supplied domestically. However, they are not required to comply with the labelling standards or advertising standards in force in Australia. Export only products are required to be listed (not registered) on the ARTG before export.
Special Access Scheme (SAS)
In the circumstances where patients need access to therapeutic goods that are not on the ARTG, access to the therapeutic good may be arranged through the SAS.
TGA reviews each access under the SAS on a case-by-case basis.
Clinical trials
TGA reviews the use of unapproved medicines to be made available to patients participating in a clinical trial.
Compliance monitoring and enforcement
Post-market activities undertaken in relation to prescription medicines include:
- providing access to a comprehensive source of up-to-date consumer medicine information and product information;
- review of Periodic Safety Update Reports to ensure the ongoing suitability of products for registration on the ARTG;
- monitoring risk management plans that detail how safety concerns will be identified and mitigated post-registration;
- ensuring that regular post-market reports are received from sponsors;
- Monitoring any international concerns about a product's safety or efficacy
- laboratory testing program on selected medicines, including random and targeted sampling of approved products;
- publishing a Medicines Safety Update in each edition of the Australian Prescriber;
- managing the problem reporting system for:
- medicine deficiency or defect
- adverse reaction to a medicine; and
- undertaking appropriate regulatory action for identified problems. Actions include:
- informing health care professionals and consumers about the risks of using the product;
- re-assessing the benefit-risk profile;
- requiring product labelling changes;
- requiring design or manufacturing change;
- requesting post-market studies;
- restricting access;
- recalling products; and
- removing the product from the ARTG.
2. Over the counter medicines
Over the counter (OTC) medicines are defined in the Therapeutic Goods Regulations 1990 (the Regulations). OTC medicines can be supplied as pharmacy medicines, pharmacist-only medicines and general sales medicines. Registered OTC medicines are considered to be of lower risk than prescription medicines, but they require an appropriate level of scrutiny.
Medicines are grouped into schedules according to the appropriate level of regulatory control over their availability to consumers. OTC medicines can be purchased for self-treatment from pharmacies, with selected products also available in supermarkets, health food stores and other retailers. Examples include cough and cold remedies, anti-fungal treatments, sunscreens, non-prescription analgesics such as aspirin and paracetamol.
OTC medicines can be registered or listed on the ARTG depending on the level of risk associated with making the product available and accessible to consumers.
Registering an OTC medicine on the ARTG
Registered OTC medicines are considered to be of relatively higher risk than listed OTC medicines, based on their substances or the indications made for the medicine. Registered medicines are evaluated for quality, safety and efficacy prior to being accepted on the ARTG and able to be marketed.
The pre-market regulatory process for OTC medicines includes:
- lodgement of an application for product registration or listing on the ARTG;
- administrative and technical screening;
- scientific evaluation;
- label assessment;
- ensuring appropriate GMP is in place;
- requesting advice from the Advisory Committee on non-prescription medicines;
- advising the sponsor of the outcome of the application process; and
- updating the ARTG.
Once a product has been registered, the sponsor can make further applications to change the details of registration. Examples of changes that may be sought include details related to labels, shelf-life, formulation, indications or directions for use.
Listing an OTC medicine on the ARTG
The listing process for an OTC medicine is the same as listing a complementary medicine which is explained in the complementary medicines section of the CRIS.
Compliance monitoring and enforcement
The OTC post-market regulatory processes include detection, compliance and enforcement:
- Detection
- undertaking laboratory testing of products (i.e. chemistry and microbiology);
- investigating reported adverse events; and
- reviewing the safety of products or classes of products.
- Compliance
- monitoring compliance with regulations;
- maintaining product registers;
- ensuring compliance with advertising regulations;
- educating stakeholders;
- recalling products;
- issuing alerts to consumers; and
- updating product information.
- Enforcement
- investigating potential breaches; and
- enforcing the regulations.
3. Complementary medicines
Medicinal products containing such ingredients as herbs, vitamins, minerals, nutritional supplements, homoeopathic and certain aromatherapy preparations are referred to as 'complementary medicines' and are regulated as medicines under the Act. Complementary medicines may be either listed or registered, depending on their ingredients and claims made for the medicine. Most complementary medicines are listed on the ARTG.
Listing a complementary medicine on the ARTG
Listed medicines are low risk medicines that are listed on the ARTG via a streamlined electronic listing facility. This process for listing products allows for early market access for low risk complementary medicines. At the time of submitting a listed medicine application, the sponsor must certify that the goods that are the subject of the application meet all of the regulatory requirements.
Unlike registered medicines, there is no evaluation prior to the medicine being listed on the ARTG. The TGA therefore uses a variety of other mechanisms to assure the safety and quality of complementary medicines, such as:
- they may only contain substances that have been previously evaluated and approved as being of low risk;
- they can only make indications (for therapeutic use) for health maintenance and health enhancement or certain indications for non-serious, self-limiting conditions;
- a proportion of listed complementary medicines are reviewed following their listing for compliance with the regulatory requirements; and
- additional substances or ingredients to be used in listed medicines may be evaluated and approved by the TGA on application from the industry. On average, there are 12 such applications received each year.
Registering a complementary medicine on the ARTG
Registered complementary medicines are considered to be of relatively higher risk than listed complementary medicines, based on their substances or the indications made for the medicine. Registered medicines are fully evaluated for quality, safety and efficacy prior to being accepted on the ARTG and able to be marketed.
Compliance monitoring and enforcement
The post-market compliance review of a listed complementary medicine involves:
- assessing information about the product against the relevant legislative requirements, including, where relevant, the certifications given by the sponsor at the time the product was listed; and
- taking appropriate actions when a breach of the legislative requirements is identified. This action may include cancellation of the listing of the medicine.
The compliance review of a listed complementary medicine may focus on one or several aspects of the medicine. Based on experience and the potential risk that non-compliance represents to the public, the TGA gives greater attention to the following three areas:
- the evidence that a sponsor holds to support the indications;
- the presentation of the medicine; and
- the advertising of the medicine.
On average, approximately 1,800 new complementary medicines are listed on the ARTG each year. Due to resource constraints, the TGA follows a risk management approach to set priorities and direct resources to those reviews that provide the greatest overall benefit for the Australian public. To assist with this determination the TGA gives priority to issues that:
- may result in immediate or potential health risk to consumers;
- could significantly mislead the Australian public, particularly in a way that could have a health impact
- are industry-wide or are likely to become widespread if the TGA does not take action;
- could lead to a loss of stakeholder confidence in regulation or in therapeutic goods;
- may attract adverse scrutiny from media or the public;
- are of national or international significance; and
- involve a new or emerging issue.
Depending on the circumstances, priority will also be given to products that have been relisted after a previous TGA-initiated cancellation or at the request of the sponsor after a previous compliance review, or where the risk or the characteristics of the medicine are of concern.
Listed complementary medicines with potential non-compliance issues may be brought to the TGA's attention from a number of sources, including the public, media, health care professionals or other external sources, referrals from within the TGA, information from other regulatory agencies and information from previous compliance reviews.
Finally, a proportion of newly listed medicines are randomly selected by computer, based on a mathematical model, for compliance review.
4. Medical devices
The Australian medical devices regulatory framework sets out the requirements for the quality, safety and performance of medical devices, based on a series of Essential Principles, rather than a prescriptive framework. All medical devices must demonstrate compliance with the Essential Principles. The extent of evidence required to demonstrate compliance with the Essential Principles is based on the risk classification of the device, with higher risk devices undergoing greater assessment prior to being allowed into the Australian market.
Regulatory activities span the life cycle of the medical device, including:
- pre-market (such as applications to include medical devices on the ARTG, conformity assessment applications and use in clinical trials); and
- post-market (such as reporting of adverse events, undertaking recalls and reviewing advertising).
As the TGA operates on a cost recovery basis, to enable pre- and post-market regulatory activity, there are a number of fees and charges for medical devices. These include annual charges, application fees, conformity assessment fees and application audit fees.
Applications to include medical devices on the ARTG
Under the Act, medical devices must be included on the ARTG prior to supply in Australia unless exempt from that requirement, such as exemption from complying with the standards under section 14 of the Act. The level of assessment conducted at the point of application for ARTG inclusion depends on the risk classification of the device, the conformity assessment evidence supporting the application, and whether there are any concerns with the application that would require the TGA to request further information for review prior to inclusion.
High-risk medical devices must have an ARTG entry for each unique device. Lower risk devices can have multiple similar devices included under one ARTG entry (a 'kind of medical device'). As the application fee is payable per ARTG entry and the value of the fee is higher for higher risk medical devices, higher risk medical devices are associated with higher overall costs.
Approval for each medical device is exclusive to the sponsor applying for inclusion, approval for one sponsor cannot be used by other sponsors, even where the medical device is identical.
While all medical devices must comply with minimum requirements for quality, safety and performance, devices other than the lowest risk, must be accompanied by conformity assessment certification following an assessment of a manufacturer's quality management system and assessment of design dossiers where applicable.
In addition to the conformity assessment certification accompanying an application for ARTG inclusion, the application process also involves a review of other information supplied with the application such as the labelling and instructions for use for the device.
Application audits
Some applications for inclusion of medical devices on the ARTG will undergo an application audit.
- Applications to include certain medical devices in the ARTG must be selected for an application audit - for these mandatory audits an application audit assessment fee is charged.
- The TGA may also select any other application for inclusion for an application audit - an audit assessment fee is not charged for these audits.
There are two levels of application audit - Level 1 and Level 2 for non-IVD medical devices and one level of application audit for IVD medical devices. If an application audit is to be conducted the TGA determines what level of application audit is appropriate for each application. There are different fees for each level of application audit, which apply if the audit is mandatory.
Conformity assessments
A conformity assessment is a systematic and ongoing examination of evidence and procedures to ensure that manufacturers of medical devices have systems and processes that provide assurance that the device conforms to the Essential Principles for quality, safety and performance.
A manufacturer must implement and maintain a post-market monitoring system for devices after supply, with reportable events reported as specified in the Regulations. A manufacturer's quality system certification may be subject to periodic surveillance audits.
For the majority of medical devices and IVDs the TGA is able to accept the assessment of conformity assessment bodies that are considered to have the appropriate authority and expertise. As the Australian and the European Union (EU) regulatory requirements are similar, certificates issued by EU conformity assessment bodies (also known as Notified Bodies) may be accepted as conformity assessment evidence for the supply of devices in Australia.
For certain higher risk medical devices and IVDs, manufacturers must obtain Conformity Assessment Certificates from the TGA for supply to the market in Australia, regardless of whether they have a certificate issued by an EU notified body. In conducting assessments for these products, the assessment will take into account any existing EU conformity assessment evidence. This requirement for TGA conformity assessment applies to medical devices containing medicinal substances or materials of animal, microbial, recombinant or human origin and Class 4 IVDs. Manufacturers may also choose to seek conformity assessment certification from TGA to support supply of their medical devices in Australia, rather than relying on certification from an EU notified body.
Clinical trials
There are two schemes under which clinical trials involving medical devices may be conducted.
- Clinical Trial Notification (CTN) Scheme - this involves a notification only with a nominal notification fee (no approval or decision is made by the TGA).
- Clinical Trial Exemption (CTX) Scheme - this process comprises an assessment of summary data and usage guidelines for a proposed clinical development programme, and if approval is granted the subsequent trials must be carried out under the terms of the approval and be notified to the TGA.
These schemes are used for clinical trials involving:
- any device not included in the ARTG; and
- use of a device in a clinical trial beyond the conditions of its marketing approval.
Other therapeutic goods listed and registered on the ARTG
A large majority of medical devices listed and registered on the ARTG prior to 2002 (previously called therapeutic devices) have now been transitioned to the new regulatory framework and are now largely regulated under Chapter 4 of the Act. There is a small number of therapeutic devices which are not captured under the new Chapter 4 arrangements. These are largely disinfectants, tampons and menstrual cups. The fees and charges included in this document for registered and listed devices apply for these products.
Post-market vigilance and monitoring, and recalls
Once a medical device has been included in the ARTG the device must continue to meet all the regulatory requirements that were required for the approval, including the requirements for safety, quality and performance.
Post-market vigilance
The TGA has mandatory requirements for all manufacturers and sponsors of medical devices. These requirements are intended to monitor information about medical devices so that appropriate action can be taken. The requirements facilitate the systematic investigation of failures and/or deviations in the way a device performs, in an attempt to prevent an adverse event occurring again. Key post-market mechanisms include:
- Reportable events:
- The TGA provides guidance as to the definition of a reportable adverse event for medical devices. There is mandatory reporting within statutory timeframes for sponsors and manufacturers of adverse events that have or could have caused a death, serious injury or serious illness and non-mandatory reporting for other events.
The outcomes of the investigations may result in recalls, hazard and safety alerts, product modification/improvement by a manufacturer, or surveillance audits of manufacturing sites.
Post-market monitoring
The TGA undertakes post-market reviews of ARTG entries of medical devices to verify compliance with the legislative requirements, such as conditions of inclusion, and to ensure continued safety and performance usually following signals that there may be an issue or a special interest in the device or a type of device.
Sponsors of Class III medical devices must also keep an up to date log of information about the performance of the device and provide annual reports for the first three years after a product receives market authorisation.
The TGA can take action to suspend or cancel a device from the ARTG where, for example, the outcomes of investigations indicate that there is a potential risk of death, serious illness or serious injury if the device continued to be included in the ARTG or if the TGA is satisfied, for instance, that the safety or performance of the device is unacceptable.
Recall actions
A recall action is an action taken to resolve a problem with therapeutic goods already supplied in the market for which there are issues or deficiencies in relation to safety, quality, efficacy (performance) or presentation. There are three distinct recall actions - recall, recall for product correction and hazard alert. Not all recall actions result in a product being removed from the market, for example, hazard alerts may be issued in cases involving implantable medical devices, and corrections may be undertaken for products that have software issues.
The TGA coordinates approximately 500 recall actions of medical devices each year. The vast majority of recalls are undertaken voluntarily by the sponsor after consultation with the TGA. For each recall action, the Recalls Unit reviews the proposed recall strategy to address the health hazard and the individual circumstances of each case. Strategies need to reflect the kind of medical device, deficiency identified, risk posed by the deficiency, distribution networks, recovery procedures, resources for corrective action and availability of alternative products. In some cases, recall action is not required but the sponsor may be required to issue a safety alert or some precautionary information in the form of a product notification.
The Recalls Unit monitors the progress of recall action by reviewing the progress reports submitted by the sponsor. In the close-out report, sponsors should provide the root cause of the problem and remedial action undertaken by the manufacturer. The report is reviewed to ensure that the root cause and the corrective action identified are appropriate to prevent the issues from recurring.
Advertising review
TGA reviews advertisements for medical devices to ensure compliance with the conditions of inclusion on the ARTG that are detailed in the Regulations and the Therapeutic Goods Advertising Code (TGAC). These advertisements may be in, but are not limited to, broadcast and mainstream print media, billboards, cinema films or the internet.
Where a complaint about a product advertisement is received, TGA will assess the validity of the complaint and, if necessary, ensure that rectifying action is undertaken.
In its review of advertising, TGA works with the following stakeholders:
- therapeutic goods industry;
- health practitioners;
- consumers;
- advertising industry;
- Australian Competition & Consumer Commission;
- Medsafe (NZ therapeutic goods regulator);
- Media;
- Therapeutic Goods Advertising Code Council; and
- Complaints Resolution Panel.
Advertisements for medical devices do not have to be approved prior to publication or broadcast. However, advertisements must comply with the conditions of inclusion on the ARTG detailed in section 41FN(5) of the Act, Division 3 and 4, Part 2 of the Regulations and the TGAC.
The Complaints Resolution Panel considers complaints about advertisements for medical devices and other therapeutic goods appearing in broadcast and mainstream print media, billboards, cinema films, the internet etc. As advertisements do not require pre-approval, the majority of activity in this area is related to assessing the validity of complaints about current advertisements that are claimed as not meeting the requirements.
TGA does not charge for lodging a complaint with the Complaints Resolution Panel. To do so would be contrary to the intent of allowing all complaints about advertising to be appropriately examined. The costs of validating complaints are recovered from sponsors of medical devices via annual charges which are linked to the maintenance of the sponsor's ARTG entry, spreading the cost of the function evenly across all products.
5. Good manufacturing practices
In Australia, manufacturers of therapeutic goods are required to hold a licence, except for manufacturers of certain medical devices who have European conformity certification (CE Mark). To obtain the licence, a manufacturer must demonstrate that they have the ability to comply with manufacturing principles, which include relevant Codes of GMP and Quality Systems, and have appropriate facilities to manufacture safely. Overseas manufacturers of therapeutic goods supplied to Australia must provide evidence of compliance with equivalent GMP standards or otherwise undergo on-site inspections in the same manner as manufacturers based in Australia.
GMP is a generally accepted term internationally to describe a set of principles and procedures that, when followed by manufacturers of medicines and biologicals, helps to insure that the products manufactured will possess the required quality.
The GMP related regulatory activities undertaken are as follows:
Licensing
TGA usually undertakes on-site inspections of Australian manufacturers prior to the issue of a licence to ensure that the manufacturer can comply with the manufacturing principles set under the Act and has suitable premises to undertake the proposed manufacturing steps. The extent of the inspection depends on the size and complexity of the manufacturing processes.
The TGA participates in international harmonisation activities to ensure that GMP requirements applied in Australia are best practice.
Monitoring compliance
The TGA undertakes periodic planned and unplanned inspections of manufacturers to assess the level of compliance with the applicable manufacturing standards, both domestically and overseas. The level and frequency of inspections for a particular manufacturer is influenced by its size and complexity but also by its compliance history. In particular, manufacturers with a history of lower levels of compliance are subject to a higher frequency of on-site inspections, compared with more compliant manufacturers, to ensure that therapeutic goods supplied in Australia are of appropriate quality and to allow TGA to take appropriate regulatory action where safety concerns are identified.
Investigation and enforcement
The TGA undertakes appropriate actions to promote and ensure compliance with the applicable GMP standards by manufacturers. Where a licensed Australian manufacturer poses unacceptable safety or quality risks, sanctions available range from (but are not limited to) revocation or suspension of the manufacturing licence to restriction of the type, kind or quantity of goods that can be manufactured for the Australian market at that site. Where required, sanctions are decided on a case-by-case basis after consideration of the circumstances involved and the best interests of the Australian consumer. Where the manufacturer is based outside of Australia, limits are placed on the ability of sponsors to make the products available on the Australian market.
Information and education
The TGA promotes compliance with the manufacturing standards by producing guidelines and other informational materials primarily targeted at manufacturers whose products are supplied in Australia. These resources are made available through the TGA website. In addition, the TGA conducts seminars and information briefings to raise awareness of regulatory requirements, particularly when changes are proposed.
TGA contributes strongly to international programs to improve and harmonise manufacturing practices in developing regions through international meetings, seminars and training events.
Policy development and services to government
The TGA provides services to Government in relation to the regulation of manufacturers, including specific technical and policy advice that is considered to be integral to the regulation of manufacturers.
Broader policy advice provided by the Department of Health is not subject to fees and charges.
6. Blood, blood components and biologicals
Blood, blood components and plasma derivatives are regulated under the Act. Plasma derivatives are prescription medicines subject to full regulation, including compliance with set standards, licensing of manufacture and inclusion in the ARTG after review of manufacturing, pre-clinical and clinical data. Under the Act 'blood' means whole blood extracted from human donors and 'blood components' means therapeutic components that have been manufactured from blood (including red cells, white cells, progenitor cells, platelets and plasma). 'Blood components' do not include products derived through fractionation of plasma.
Some blood and blood components are exempt from regulation by TGA, including those:
- collected by a medical practitioner in the course of medical treatment and for the purposes of diagnosis or testing for a medical condition;
- manufactured by a medical practitioner for therapeutic application to a particular patient under the practitioner's care; and
- manufactured by a blood collection centre for a medical practitioner for therapeutic application to a particular patient under the practitioner's care.
Manufacturers of blood components are required to demonstrate compliance with manufacturing principles equivalent to the Australian Code of Good Manufacturing for human blood and blood components, human tissues and human cellular therapy products (2013) and to submit a technical master file which demonstrates compliance to relevant standards.
Biologicals include human tissue and cell therapy products. Tissue therapy products involve the use of tissues as therapeutic goods, while cell therapy products involve the use of isolated living cells either as therapeutic goods or as replacements for cells that are defective or deficient in particular disorders.
Some examples of tissue therapies currently being used are:
- skin replacement after severe burns;
- transplantation of heart, kidney, liver, lung or pancreas;
- bone, tendons and ligaments to repair injuries;
- heart valves to replace defective heart valves; and
- corneas to restore eyesight.
Some examples of cell therapies currently being used, or currently under development are:
- chondrocytes used for cartilage regeneration;
- isolated pancreatic islet cells for the treatment of diabetes; and
- mesenchymal progenitor cells for the treatment of musculoskeletal defects and in a range of other clinical applications such as cardiovascular repair.
Inclusion on the ARTG
The regulatory activities for biologicals involve the following registration and approval activities:
- management of applications for inclusion in the ARTG;
- sponsors of Class 1 biologicals are required to attest compliance with relevant mandatory standards;
- Class 2, 3 and 4 biologicals undergo pre-market evaluation prior to ARTG inclusion;
- highly manipulated Class 3 and 4 biologicals are subject to the highest levels of pre-market evaluation; and
- manufacturers of Class 2, 3 and 4 biologicals are required to demonstrate compliance with manufacturing principles equivalent to the Australian Code of Good Manufacturing for human blood and blood components, human tissues and human cellular therapy products (2013).
Compliance monitoring and enforcement
- Post-market controls include ongoing manufacturing inspections, managing adverse event reporting, investigations and recalls.
- The TGA also provides information and support to the regulated industry and consumers and is responsible for the maintenance of the regulatory framework.